PALSONIFY
PALTUSOTINE
Cri
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1528668 | 1000136409 | Criterion Tool & Die Inc DBA Criterion Precision Machining | 1 | N | 2026-01-01 | Criterion Tool & Die Inc Dba Criterion Precision Machining 5349 W 161st St Brookpark OH US 44142 |
| 1922662 | 1922662 | CRISS OPTICAL MFG. CO., INC. | 1 | N | 2026-01-01 | 3628 S WEST ST WICHITA KS US 67217 |
| 3003114240 | 3003114240 | Cristina Babin | 1 | N | 2026-01-01 | 6670 185th Avenue NE Redmond WA US 98052 |
| 3006801236 | 3006801236 | Cristiano Gorgaini | 1 | N | 2026-01-01 | 18 Bridge Street Unit 2A Brooklyn NY US 11201 |
| 3008627398 | 3008627398 | Cristcot LLC | 1 | N | 2026-01-01 | 901 S. Mopac Expressway Building 3, Suite 375 Austin TX US 78746 |
| 3008994129 | 3008994129 | CRITERION , INC. | 1 | Y | 2026-01-01 | 1450 Vasser Street Reno NV US 89502 |
| 3012238587 | 3012238587 | CRITICARE TECHNOLOGIES, INC. | 1 | N | 2026-01-01 | 333 Strawberry Field Rd Suite 11 Warwick RI US 02886 |
| 3014021001 | 3014021001 | CRITICAL INNOVATIONS LLC | 1 | N | 2026-01-01 | 4228 Marine Avenue Lawndale CA US 90260 |
| 3021286067 | 3021286067 | CRITICOR, INC. | 1 | Y | 2026-01-01 | 2650 Walnut Avenue Suite I Tustin CA US 92780 |
| 3035691085 | 3035691085 | CRISTALINE ALIGNERS GMBH | 1 | N | 2026-01-01 | Hanauer Strasse 1-5 Pforzheim Baden-Wurttemberg DE 75181 |
| 3008661376 | 3008661376 | CRITICAL DIAGNOSTICS | 1 | N | 2020-04-25 | 3030 Bunker Hill St Ste 117A San Diego CA US 92109 |
| 3014020289 | 3014020289 | CRIUS PACIFIC MEDICAL INC. | 1 | Y | 2020-04-25 | 458 san mateo ave. San Bruno CA US 94066 |
| 3014141540 | 3014141540 | CRI GENETICS | 1 | Y | 2020-04-25 | 2425 Olympic Blvd Suite 4000 W Santa Monica CA US 90404 |
| 3014232461 | 3014232461 | Cristopher Cheng | 1 | N | 2020-04-25 | 1731 Holt Avenue Los Altos CA US 94022 |
| 3015727415 | 3015727415 | CRITERION CHEMISTRIES | 1 | N | 2020-04-25 | 490 Wildwood North Circle Ste 110 Birmingham AL US 35209 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 192528 | 1839132170 | K884216 | 506 NON-INVASIVE VITAL SIGNS MONITOR | DSI | 1989-03-16 |
| 335999 | 1534908710 | K242892 | Cristaline Aligners Z FLX | NXC | 2024-12-19 |
| 178084 | 1251373761 | K121719 | SM TENS & PMS | NGX | 2013-05-10 |
| 132758 | 1051988255 | K111452 | PRESAGE ST2 ASSAY | OYG | 2011-12-09 |
| 192528 | 1003668053 | K101602 | VITAL SIGNS MONITOR | MLD | 2010-09-01 |
| 120874 | 1613596252 | K092829 | INSERTEASE | OOW | 2009-12-02 |
| 192528 | 1860773766 | K091050 | 506CN PATIENT MONITOR | DRT | 2009-05-27 |
| 192528 | 1956637267 | K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 | MHX | 2003-04-17 |
| 192528 | 1790382423 | K012059 | 8100/8500 VITAL SIGNS MONITOR | MWI | 2001-08-01 |
| 73752 | 1200234984 | ||||
| 214718 | 1396365202 | ||||
| 211219 | 1564439611 | ||||
| 214718 | 1671741439 | ||||
| 232172 | 1831392985 | ||||
| 214718 | 2019852749 | ||||
| 73752 | 1218284977 | ||||
| 211219 | 1293830186 | ||||
| 45669 | 1316063761 | ||||
| 45669 | 1365980866 | ||||
| 45669 | 1480721103 | ||||
| 73752 | 1542621646 | ||||
| 73752 | 1546652043 | ||||
| 211753 | 1552757945 | ||||
| 73752 | 1567738627 | ||||
| 45669 | 1596205784 | ||||
| 1184 | 1609169791 | ||||
| 45669 | 1713729456 | ||||
| 45669 | 1729408707 | ||||
| 120874 | 1824349922 | ||||
| 45669 | 1827052234 | ||||
| 45669 | 1855576203 | ||||
| 45669 | 1882779859 | ||||
| 73752 | 1942360119 | ||||
| 45669 | 2041310361 | ||||
| 73752 | 2046792276 |
Product Codes Associated With Registrations#
NDC#
PALSONIFY
PALTUSOTINE
PMN#
Cristaline Aligners Z FLX
Cristaline Aligners GmbH
Lumina-PTFE Titanium
Criteria Industria E Comercio DE Produtos Medicinais
Critical Alert CommonPath Enterprise
Critical Alert
PRESAGE ST2 ASSAY
CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG
CRITICAL CARE ASSESSMENT
CRITICAL PATIENT CARE, INC.
VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC.
506CN PATIENT MONITOR
CRITICARE SYSTEMS, INC.
CRITIVIEW, MODEL CRV3
CRITISENSE LTD.
CRITIVIEW
CRITISENSE LTD.
8600 VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC.
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
CRITICARE SYSTEMS, INC.
507EL VITAL SIGNS MONITOR
Criticare Systems, Inc.
8100/8500 VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC.
DINAMAP PRO 1000 MONITOR, MODEL 1000
CRITIKON COMPANY,LLC
DINAMAP ADVANCED NIBP MODULE
CRITIKON COMPANY, L.L.C.
8100 VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC.
MPT 24 AND VITAL VIEW 24
CRITICARE SYSTEMS, INC.
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
CRITIKON COMPANY,LLC
MPS GRAVITY FLOW CONTROL SET
CRITICAL DEVICE CORP.
DINAMAP MPS SELECT PORTABLE MONITOR
CRITIKON COMPANY,LLC
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
CRITICAL DEVICE CORP.
CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
CRITICAL DEVICE CORP.
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
CRITICAL DEVICE CORP.
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
CRITICARE SYSTEMS, INC.
NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
CRITICAL DEVICE CORP.
MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
CRITICAL DEVICE CORP.
SCHOLAR PATIENT MONITOR
CRITICARE SYSTEMS, INC.
DINAMAP PLUS VITAL SIGNS MONOITOR
CRITIKON COMPANY,LLC
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
CRITIKON COMPANY,LLC
POET IQ WITH FIVE AGENT CAPABILITY
CRITICARE SYSTEMS, INC.
MAG-1 SPECTACLE FRAME
CRISS OPTICAL MFG. CO., INC.
CRITIKON CENTRAL STATIN MONITOR
CRITIKON COMPANY,LLC
MODEL 508 PATIENT MONITOR
CRITICARE SYSTEMS, INC.
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
CRITIKON COMPANY,LLC
CRITIKON VITAL SIGNS MODULE
CRITIKON COMPANY,LLC
INTRAVENOUS CATHETERS MODIFICATIONS
CRITIKON COMPANY,LLC
MODEL P-81 CRITIKON PRINTER
CRITKON, INC.
DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700
CRITIKON COMPANY,LLC
507 NON-INVASIVE VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC.
503 PULSE OXIMETER
CRITICARE SYSTEMS, INC.