Richard Wolf G M B H

FDA Filings

This page includes the latest FDA filings for Richard Wolf G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9611102
• FEI Number: 3002808001
• Name: RICHARD WOLF GMBH
• Owner & Operator: RICHARD WOLF GMBH
• Contact Address: PFORZHEIMER STR. 32 --; KNITTLINGEN DE-NOTA 75438 DE
• Official Correspondent:
  • Mike Loiterman
  • 49-49-704335-0
• US Agent:
  • Mike Loiterman
  • RICHARD WOLF MEDICAL INSTRUMENTS CORP.
  • 847 9131113 380
  • 847 9130924
  • MLoiterman@richardwolfusa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: PFORZHEIMER STR. 32 ; KNITTLINGEN Baden-Wurttemberg, 75438 DE
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198
  • Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 1418479
• FEI Number: 1418479
• Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• Owner & Operator: RICHARD WOLF GMBH
• Contact Address: PFORZHEIMER STR. 32 --; KNITTLINGEN DE-NOTA 75438 DE
• Official Correspondent:
  • Mike Loiterman
  • 49-49-704335-0
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 353 CORPORATE WOODS PKWY. ; VERNON HILLS, IL 60061 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Remanufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 04055207043011 Richard Wolf GmbH	8734.686 8734.686	2025-01-13
GUDID 04055207042991 Richard Wolf GmbH	8734.656 8734.656	2025-01-13
GUDID 04055207066225 Richard Wolf GmbH	E-LINE 86500545S01	2025-01-10
GUDID 04055207066218 Richard Wolf GmbH	E-LINE 86500445S01	2025-01-10
GUDID 04055207028902 Richard Wolf GmbH	HYSAFE 8954.6808	2025-01-09
GUDID 00814334022252 Richard Wolf GmbH	4256104463US 4256104463US	2025-01-09
GUDID 00814334022238 Richard Wolf GmbH	4256204463US 4256204463US	2025-01-08
GUDID 00814334022214 Richard Wolf GmbH	4256305463US 4256305463US	2025-01-06
GUDID 04055207008195 Richard Wolf GmbH	828.07 828.07	2024-12-05
GUDID 04055207028865 Richard Wolf GmbH	HYSAFE 8952.6118	2024-12-02
GUDID 04055207027813 Richard Wolf GmbH	HYSAFE 8645.6008	2024-12-02
GUDID 04055207066201 Richard Wolf GmbH	E-LINE 86500345S01	2024-11-29
GUDID 04055207066195 Richard Wolf GmbH	E-LINE 86500245S01	2024-11-29
GUDID 04055207028933 Richard Wolf GmbH	HYSAFE 8959.6808	2024-11-29
GUDID 04055207028926 Richard Wolf GmbH	HYSAFE 8959.6218	2024-11-29
GUDID 04055207028889 Richard Wolf GmbH	HYSAFE 8952.6508	2024-11-29
GUDID 04055207028872 Richard Wolf GmbH	HYSAFE 8952.6218	2024-11-29
GUDID 04055207028858 Richard Wolf GmbH	HYSAFE 8952.6008	2024-11-29
GUDID 04055207027820 Richard Wolf GmbH	HYSAFE 8645.6508	2024-11-29
GUDID 04055207027806 Richard Wolf GmbH	HYSAFE 8642.6818	2024-11-29
GUDID 04055207027790 Richard Wolf GmbH	HYSAFE 8642.6508	2024-11-29
GUDID 04055207027783 Richard Wolf GmbH	HYSAFE 8642.6318	2024-11-29
GUDID 04055207065730 Richard Wolf GmbH	VERTEBRIS 15208.264	2024-11-21
GUDID 04055207065679 Richard Wolf GmbH	VERTEBRIS 15208.257	2024-11-21
GUDID 04055207063248 Richard Wolf GmbH	RIWO 5257171	2024-11-21
GUDID 04055207063231 Richard Wolf GmbH	RIWO 5257141	2024-11-21
GUDID 04055207063019 Richard Wolf GmbH	892209304 892209304	2024-11-21
GUDID 04055207063002 Richard Wolf GmbH	PERCULINE 892209104	2024-11-21
GUDID 04055207062999 Richard Wolf GmbH	PERCULINE 892209204	2024-11-21
GUDID 04055207062975 Richard Wolf GmbH	VERTEBRIS 892209007	2024-11-21
GUDID 04055207062968 Richard Wolf GmbH	VERTEBRIS 892209008	2024-11-21
GUDID 04055207062951 Richard Wolf GmbH	VERTEBRIS 892209009	2024-11-21
GUDID 04055207061244 Richard Wolf GmbH	8393.501 8393.501	2024-11-21
GUDID 04055207061237 Richard Wolf GmbH	8393.502 8393.502	2024-11-21
GUDID 04055207061220 Richard Wolf GmbH	8393.503 8393.503	2024-11-21
GUDID 04055207061213 Richard Wolf GmbH	8393.511 8393.511	2024-11-21
GUDID 04055207061206 Richard Wolf GmbH	8393.512 8393.512	2024-11-21
GUDID 04055207060582 Richard Wolf GmbH	8394.502 8394.502	2024-11-21
GUDID 04055207060575 Richard Wolf GmbH	8394.503 8394.503	2024-11-21
GUDID 04055207060568 Richard Wolf GmbH	8394.511 8394.511	2024-11-21
GUDID 04055207060551 Richard Wolf GmbH	8394.512 8394.512	2024-11-21
GUDID 04055207058817 Richard Wolf GmbH	5261504 5261504	2024-11-21
GUDID 04055207056271 Richard Wolf GmbH	ERAGON MODULAR 8396902	2024-11-21
GUDID 04055207056233 Richard Wolf GmbH	TIPCONTROL 15570644	2024-11-21
GUDID 04055207056226 Richard Wolf GmbH	TIPCONTROL 15570643	2024-11-21
GUDID 04055207047019 Richard Wolf GmbH	89270.2025 89270.2025	2024-11-21
GUDID 04055207046906 Richard Wolf GmbH	VERTEBRIS 89240.1052	2024-11-21
GUDID 04055207046869 Richard Wolf GmbH	VERTEBRIS 89220.3008	2024-11-21
GUDID 04055207046852 Richard Wolf GmbH	VERTEBRIS 89220.3007	2024-11-21
GUDID 04055207046845 Richard Wolf GmbH	VERTEBRIS 89220.1408	2024-11-21
GUDID 04055207046821 Richard Wolf GmbH	VERTEBRIS 89220.1167	2024-11-21
GUDID 04055207046814 Richard Wolf GmbH	VERTEBRIS 89220.1157	2024-11-21
GUDID 04055207046777 Richard Wolf GmbH	VERTEBRIS 89220.1098	2024-11-21
GUDID 04055207046760 Richard Wolf GmbH	VERTEBRIS 89220.1088	2024-11-21
GUDID 04055207046746 Richard Wolf GmbH	VERTEBRIS 89220.1078	2024-11-21
GUDID 04055207046715 Richard Wolf GmbH	VERTEBRIS 89220.1047	2024-11-21
GUDID 04055207044544 Richard Wolf GmbH	8871.721 8871.721	2024-11-21
GUDID 04055207042526 Richard Wolf GmbH	8436.701 8436.701	2024-11-21
GUDID 04055207040799 Richard Wolf GmbH	8863.80 8863.80	2024-11-21
GUDID 04055207039649 Richard Wolf GmbH	8291.45 8291.45	2024-11-21
GUDID 04055207039625 Richard Wolf GmbH	8291.24 8291.24	2024-11-21
GUDID 04055207039618 Richard Wolf GmbH	8291.23 8291.23	2024-11-21
GUDID 04055207039601 Richard Wolf GmbH	8291.22 8291.22	2024-11-21
GUDID 04055207039557 Richard Wolf GmbH	8283.51 8283.51	2024-11-21
GUDID 04055207039199 Richard Wolf GmbH	8267.50 8267.50	2024-11-21
GUDID 04055207038819 Richard Wolf GmbH	8150.19 8150.19	2024-11-21
GUDID 04055207035290 Richard Wolf GmbH	VERTEBRIS 892209010	2024-11-21
GUDID 04055207035283 Richard Wolf GmbH	VERTEBRIS 892207017	2024-11-21
GUDID 04055207035276 Richard Wolf GmbH	VERTEBRIS 892207007	2024-11-21
GUDID 04055207035122 Richard Wolf GmbH	VERTEBRIS 89220.1007	2024-11-21
GUDID 04055207028995 Richard Wolf GmbH	HYSAFE 8962.6108	2024-11-21
GUDID 04055207028988 Richard Wolf GmbH	HYSAFE 8962.6078	2024-11-21
GUDID 04055207028971 Richard Wolf GmbH	HYSAFE 8962.6058	2024-11-21
GUDID 04055207028964 Richard Wolf GmbH	HYSAFE 8962.6048	2024-11-21
GUDID 04055207028957 Richard Wolf GmbH	HYSAFE 8962.6028	2024-11-21
GUDID 04055207028940 Richard Wolf GmbH	HYSAFE 8962.6008	2024-11-21
GUDID 04055207027776 Richard Wolf GmbH	HYSAFE 8642.6008	2024-11-21
GUDID 04055207027318 Richard Wolf GmbH	RIWO 85261504	2024-11-21
GUDID 04055207027257 Richard Wolf GmbH	RIWO 85261244	2024-11-21
GUDID 04055207027219 Richard Wolf GmbH	RIWO 85261144	2024-11-21
GUDID 04055207020951 Richard Wolf GmbH	8840.604 8840.604	2024-11-21
GUDID 04055207020753 Richard Wolf GmbH	VERTEBRIS 8792.623	2024-11-21
GUDID 04055207020494 Richard Wolf GmbH	8756.201 8756.201	2024-11-21
GUDID 04055207016855 Richard Wolf GmbH	ERAGON MODULAR 8397.654	2024-11-21
GUDID 04055207016589 Richard Wolf GmbH	8394.506 8394.506	2024-11-21
GUDID 04055207016572 Richard Wolf GmbH	8394.505 8394.505	2024-11-21
GUDID 04055207016138 Richard Wolf GmbH	8393.505 8393.505	2024-11-21
GUDID 04055207016121 Richard Wolf GmbH	8393.504 8393.504	2024-11-21
GUDID 04055207009109 Richard Wolf GmbH	8095.05 8095.05	2024-11-21
GUDID 00814334022795 Richard Wolf GmbH	409903930US 409903930US	2024-11-21
GUDID 00814334022771 Richard Wolf GmbH	409903730US 409903730US	2024-11-21
GUDID 00814334022276 Richard Wolf GmbH	409903940US 409903940US	2024-11-21
GUDID 04055207034446 Richard Wolf GmbH	891237012 891237012	2024-10-08
GUDID 04055207069981 Richard Wolf GmbH	RIWO 88.005	2024-08-27
GUDID 04055207069974 Richard Wolf GmbH	89.141 89.141	2024-08-27
GUDID 04055207069936 Richard Wolf GmbH	89.10 89.10	2024-08-27
GUDID 04055207069912 Richard Wolf GmbH	89.08 89.08	2024-08-27
GUDID 04055207069899 Richard Wolf GmbH	89.03 89.03	2024-08-27
GUDID 04055207069882 Richard Wolf GmbH	89.02 89.02	2024-08-27
GUDID 04055207069875 Richard Wolf GmbH	89.01 89.01	2024-08-27
FCT RICHARD WOLF MEDICAL INSTRUMENTS CORP. [RICHARD WOLF GMBH]	Headlamp 4526.00	2018-09-24
FCT RICHARD WOLF GMBH	Headlamp 4526.00	2018-09-24
PMN K180583 | FET RICHARD WOLF MEDICAL INSTRUMENTS CORP. [RICHARD WOLF GMBH]	LOGIC 4K Camera Controller 5525301 and LOGIC 4K Camera Head 85525942	2018-06-29
PMN K180583 | FET RICHARD WOLF GMBH	LOGIC 4K Camera Controller 5525301 and LOGIC 4K Camera Head 85525942	2018-06-29
PMN K962799 RICHARD WOLF GMBH	MINIATURE LAPAROSCOPE SET (MINI LAP)	1996-10-11

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020041517406	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	FURNITURE	26 PKG
2020040645674	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	FURNITURE	26 PKG
2019082056455	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	METAL FURNITURES FOR HOSPITALS	26 PKG