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
7489–7512 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 11, 2001
CHURCHILL MEDICAL SYSTEMS STOPCOCK
K012157 · FMG
Churchill Medical Systems, Inc.
General Hospital · 62d
Cleared Sep 10, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR...
K011044 · LYY
Shen Wei (Usa), Inc.
General Hospital · 158d
Cleared Sep 10, 2001
PRESSURE ACTIVATED CHECK VALVE
K011888 · FPA
Churchill Medical Systems, Inc.
General Hospital · 84d
Cleared Sep 10, 2001
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · FLL
Avita Corporation
General Hospital · 63d
Cleared Sep 10, 2001
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800,...
K012229 · FMT
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 10, 2001
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · LJS
C.R. Bard, Inc.
General Hospital · 12d
Cleared Sep 05, 2001
JMS APHERESIS NEEDLE SET ACCORDION TYPE
K002394 · FMI
Jms Co., Ltd.
General Hospital · 394d
Cleared Sep 05, 2001
CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND...
K012573 · FLE
Getinge/Castle, Inc.
General Hospital · 27d
Cleared Sep 04, 2001
ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
K011868 · LZH
Debio Tech SA
General Hospital · 82d
Cleared Aug 30, 2001
EXEL I.V. ADMINISTRATION SET
K010404 · FPA
Exelint Intl. Co.
General Hospital · 199d
Cleared Aug 29, 2001
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
K003555 · MEG
Spectrum Biotech, Inc.
General Hospital · 285d
Cleared Aug 29, 2001
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
K011984 · FMI
Becton, Dickinson & CO
General Hospital · 64d
Cleared Aug 28, 2001
TRULINE INFUSION CATHETERS
K011937 · FOZ
Micro Therapeutics, Inc.
General Hospital · 68d
Cleared Aug 28, 2001
BI-PHASIC INFILTRATOR
K012044 · FRN
Reliance Medical Corp.
General Hospital · 60d
Cleared Aug 27, 2001
TERUMO 30 GAUGE HYPODERMIC NEEDLE
K012646 · FMI
Terumo Medical Corp.
General Hospital · 14d
Cleared Aug 27, 2001
EZ SET INFUSION SET
K012754 · FPA
Animas Corp.
General Hospital · 11d
Cleared Aug 22, 2001
SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1
K001853 · FMI
Medtech Systems, Inc.
General Hospital · 429d
Cleared Aug 22, 2001
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
K011749 · LYY
Sempermed USA, Inc.
General Hospital · 83d
Cleared Aug 21, 2001
SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
K012104 · KGO
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 47d
Cleared Aug 20, 2001
TEMP 3
K012276 · LGZ
Medical Solutions, Inc.
General Hospital · 32d
Cleared Aug 16, 2001
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
K011765 · LZA
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 70d
Cleared Aug 16, 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 48d
Cleared Aug 14, 2001
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
K011717 · LZA
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 71d
Cleared Aug 14, 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · KGO
Allegiance Healthcare Corp.
General Hospital · 71d