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
9817–9840 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 27, 1996
COMFIT
K953590 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 332d
Cleared Jun 27, 1996
SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE
K955918 · LYY
Sinochem Ningbo Imp & Exp Corp.
General Hospital · 190d
Cleared Jun 27, 1996
SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES
K960746 · LYZ
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 125d
Cleared Jun 27, 1996
EASTERCLAVE
K961230 · FLE
Easter Services, Inc.
General Hospital · 90d
Cleared Jun 27, 1996
PUNCTUR-GUARD WINGED SET
K961251 · FMI
Bio-Plexus, Inc.
General Hospital · 87d
Cleared Jun 27, 1996
SHARPS-TAINER
K961878 · FMI
Winfield Industries
General Hospital · 43d
Cleared Jun 26, 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK...
K961495 · FPA
Baxter Healthcare Corp
General Hospital · 69d
Cleared Jun 25, 1996
GE STERILE ARTHROGRAM TRAY
K962035 · FMI
GE Medical Systems
General Hospital · 32d
Cleared Jun 25, 1996
RNS ARTHROGRAM TRAY
K962040 · FMI
Contour Fabricators of Florida, Inc.
General Hospital · 32d
Cleared Jun 21, 1996
LUMISCOPE MODEL 2018 THERMOMETER
K954792 · FLL
Lumiscope Co., Inc.
General Hospital · 247d
Cleared Jun 21, 1996
HANDSAFE
K960386 · LYY
Handsafe Products Sdn. Bhd.
General Hospital · 147d
Cleared Jun 21, 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225 · FPA
Baxter Healthcare Corp
General Hospital · 84d
Cleared Jun 18, 1996
SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
K961155 · LJS
Douglas Medical Products Corp.
General Hospital · 88d
Cleared Jun 17, 1996
VYGON PREMI-CATH - LONG TERM CATHETER
K954302 · LJS
Vygon Corp.
General Hospital · 278d
Cleared Jun 14, 1996
POWERED LOW AIR LOSS MATTRESS SYSTEM
K961159 · FNM
Span-America Medical Systems, Inc.
General Hospital · 84d
Cleared Jun 10, 1996
OSTAR
K955424 · LYY
Ultravena Industries, Ltd.
General Hospital · 195d
Cleared Jun 10, 1996
OSTAR EXAMINATION GLOVES
K955947 · LYY
Contract Latex Dippers Sdn Bhd
General Hospital · 195d
Cleared Jun 10, 1996
JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
K961227 · FRG
J.J. Skinner, Inc.
General Hospital · 74d
Cleared Jun 10, 1996
POS-T-VAC ID-300
K961309 · KZH
Pos-T-Vac, Inc.
General Hospital · 67d
Cleared Jun 10, 1996
ELECTRONIC THERMOMETER
K961879 · FLL
Wiltec Industries , Ltd.
General Hospital · 26d
Cleared Jun 05, 1996
GLOVE SEAL & SET-RITE
K954063 · LYY
Contract Latex Dippers Sdn Bhd
General Hospital · 281d
Cleared Jun 05, 1996
ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
K960045 · KKX
The Sewing Source, Inc.
General Hospital · 155d
Cleared Jun 04, 1996
EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK
K960957 · FRN
Sims Deltec, Inc.
General Hospital · 85d
Cleared Jun 03, 1996
3030 INFUSION PUMP
K955258 · FRN
Sabratek Corp.
General Hospital · 200d