FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
3937–3960 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 26, 2013
ULTRASAFE PLUS PASSIVE NEEDLE GUARD
K123743 · MEG
Safety Syringes, Inc.
General Hospital · 110d
Cleared Mar 26, 2013
SMART-WELL INCUBATOR
K122362 · FRC
Mesa Laboratories, Inc.
General Hospital · 232d
Cleared Mar 20, 2013
BD ALCOHOL SWAB
K121655 · LKB
Becton, Dickinson & CO
General Hospital · 288d
Cleared Mar 19, 2013
ORBIT INFUSION SET
K130468 · FPA
Ypsomed AG
General Hospital · 22d
Cleared Mar 18, 2013
STERILE LATEX SURGICAL GLOVE
K123628 · KGO
Lucenxia Prescience AG
General Hospital · 115d
Cleared Mar 18, 2013
3M ATTEST(TM) AUTO-READER
K123546 · FRC
3M Company
General Hospital · 119d
Cleared Mar 18, 2013
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
K122702 · ONT
Filligent Limited
General Hospital · 195d
Cleared Mar 15, 2013
3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER...
K121593 · FRC
3M Company
General Hospital · 288d
Cleared Mar 13, 2013
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K124053 · FRN
Carticept Medical, Inc.
General Hospital · 72d
Cleared Mar 13, 2013
VISIOFOCUS
K122412 · FLL
Tecnimed S.R.L.
General Hospital · 217d
Cleared Mar 12, 2013
GETINGE 400HC-E / SERIES STEAM STERILIZER
K122071 · FLE
Getinge Sourcing, LLC
General Hospital · 239d
Cleared Mar 11, 2013
GYNECOLOGY STERILIZATION TRAY
K121904 · KCT
Smith & Nephew Inc., Endoscopy Division
General Hospital · 255d
Cleared Mar 08, 2013
UNI-PICC
K130034 · LJS
Health Line International Corporation
General Hospital · 60d
Cleared Mar 07, 2013
LITTLE ANGELS SWADDLING BLANKET
K123411 · PDH
Bionix Development Corp.
General Hospital · 122d
Cleared Mar 07, 2013
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
K123344 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 127d
Cleared Mar 07, 2013
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
K121511 · FPA
Maclin Power, Inc.
General Hospital · 290d
Cleared Mar 05, 2013
MULTIPLE NAME
K123819 · LYY
Top Calibre Sdn Bhd
General Hospital · 83d
Cleared Mar 05, 2013
JMS SAFE WING CATH (SWC)
K121488 · FOZ
JMS North America Corporation
General Hospital · 291d
Cleared Mar 01, 2013
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH...
K130245 · FMG
Baxter Healthcare Corp
General Hospital · 29d
Cleared Mar 01, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
K123749 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 85d
Cleared Feb 28, 2013
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K123869 · LZA
Dehai (Shandong) Medical Gloves, Co.,...
General Hospital · 73d
Cleared Feb 28, 2013
DURABLUE STERILIZATION WRAP
K123289 · FRG
Cardinal Health-Medical Products and...
General Hospital · 129d
Cleared Feb 28, 2013
GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
K121999 · FLL
Draeger Medical GmbH
General Hospital · 234d
Cleared Feb 27, 2013
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
K130197 · ONB
Becton, Dickinson and Company
General Hospital · 30d