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
7681–7704 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 28, 2001
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
K010616 · FRF
Hmi Industries, Inc.
General Hospital · 27d
Cleared Mar 27, 2001
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
K010347 · LYY
Enzymic Technologies Sdn Bhd
General Hospital · 50d
Cleared Mar 27, 2001
LATEX EXAMINATION GLOVES-POWDER FREE
K010356 · LYY
Enzymic Technologies Sdn Bhd
General Hospital · 50d
Cleared Mar 21, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 124d
Cleared Mar 21, 2001
OHMEDA MEDICAL GIRAFFE INCUBATOR
K010222 · FMZ
Ohmeda Medical
General Hospital · 56d
Cleared Mar 18, 2001
4 PORT, 4 WAY STOPCOCK
K010217 · FMG
George Loo, MD
General Hospital · 53d
Cleared Mar 18, 2001
NPAC MULTI-USE THERMOMETER, MODEL TD400
K010224 · FLL
Norm Pacific Automation Corp.
General Hospital · 53d
Cleared Mar 15, 2001
SURSHIELD WINGED INFUSION SET
K010103 · FPA
Terumo Medical Corp.
General Hospital · 62d
Cleared Mar 14, 2001
INNOVO
K010359 · FMF
Novo Nordisk A/S
General Hospital · 36d
Cleared Mar 13, 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND...
K010373 · FPA
Sterling Medivations, Inc.
General Hospital · 34d
Cleared Mar 12, 2001
BD VISIDRAPE OPHTHALMIC DRAPES
K010572 · KKX
Becton, Dickinson and Co.
General Hospital · 14d
Cleared Mar 09, 2001
SLEEVED FILTER
K010040 · CAH
King Systems Corp.
General Hospital · 63d
Cleared Mar 09, 2001
CENTURA PHOTOTHERAPY SPOTLIGHT
K010495 · LBI
Medical Illumination International, Inc.
General Hospital · 17d
Cleared Mar 08, 2001
SEROJET
K003908 · KZE
Bioject, Inc.
General Hospital · 79d
Cleared Mar 08, 2001
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE...
K010426 · LJT
Sims Deltec, Inc.
General Hospital · 23d
Cleared Mar 06, 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · FPA
Quest Medical, Inc.
General Hospital · 189d
Cleared Mar 06, 2001
INJEX 50 SYSTEM
K003864 · KZE
Equidyne Systems, Inc.
General Hospital · 83d
Cleared Mar 01, 2001
BD ECLIPSE HYPODERMIC NEEDLE
K010188 · FMI
Bd Medical Systems
General Hospital · 38d
Cleared Feb 28, 2001
MAC ACUPUNCTURE NEEDLE
K002827 · MQX
Haenglim Seowon Corp.
General Hospital · 170d
Cleared Feb 28, 2001
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
K010077 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Feb 28, 2001
DUAL LUMEN MIDLINE CATHETER
K010349 · LJS
Catheter Innovations, Inc.
General Hospital · 23d
Cleared Feb 27, 2001
MODEL THERMO TEK QUICKCARE
K010502 · FLL
Saat , Ltd.
General Hospital · 6d
Cleared Feb 23, 2001
MAEDA NEW NEEDLE DISPOSABLE
K000581 · MQX
Maeda Toyokichi Shoten
General Hospital · 367d
Cleared Feb 23, 2001
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
K003749 · FYC
Banta Healthcare
General Hospital · 81d