FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,754 results
9793–9816 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jun 03, 1996
WHEELED STRETCHER
K961437 · FPO
Hill-Rom, Inc.
General Hospital · 49d
Cleared May 30, 1996
BEC SHROUDED PLASTIC CANNULA
K961328 · FMI
Biological & Environmental Control...
General Hospital · 52d
Cleared May 29, 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · FPA
Abbott Laboratories
General Hospital · 267d
Cleared May 29, 1996
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · LHI
Abbott Laboratories
General Hospital · 148d
Cleared May 28, 1996
PERRY SPECIALTIES DESIGNS NEEDLE GUARD
K932889 · FMI
Perry Specialties Design, Inc.
General Hospital · 1079d
Cleared May 28, 1996
HIGH RISK GLOVES
K955241 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 195d
Cleared May 24, 1996
TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)
K954258 · LJT
Gerard Medical Enterprises, Inc.
General Hospital · 262d
Cleared May 24, 1996
DISETRONIC MULTIFUSE PUMP SYSTEM
K954826 · FRN
Disetronic Medical Systems
General Hospital · 217d
Cleared May 24, 1996
BRANNON PEDI PORTSYRINGE
K960047 · FMF
James K. Brannon
General Hospital · 143d
Cleared May 24, 1996
BRANNON PORTSYRINGE
K960049 · FMF
James K. Brannon
General Hospital · 143d
Cleared May 24, 1996
POWDER FREE LATEX EXAMINATION GLOVE
K960467 · LYY
Biopro, Inc.
General Hospital · 115d
Cleared May 23, 1996
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP
K955180 · FRN
Sims Deltec, Inc.
General Hospital · 192d
Cleared May 23, 1996
MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR
K960777 · FRC
Mdt Corp., Inc.
General Hospital · 87d