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
9505–9528 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 31, 1996
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127 · GCX
Allegiance Healthcare Corp.
General Hospital · 77d
Cleared Dec 31, 1996
TAKI ACUPUNCTURE NEEDLES
K964411 · MQX
Lhasa Medical, Inc.
General Hospital · 83d
Cleared Dec 31, 1996
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
K964515 · FNL
M.C. Healthcare Products, Inc.
General Hospital · 76d
Cleared Dec 30, 1996
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
K955425 · LYY
Dash Medical Gloves Sdn Bhd
General Hospital · 398d
Cleared Dec 30, 1996
ISOLATION GOWN
K960999 · FYC
Copioumed Intl., Inc.
General Hospital · 293d
Cleared Dec 30, 1996
SHOE COVER, NON-STERILE
K961342 · FXP
Copioumed Intl., Inc.
General Hospital · 285d
Cleared Dec 30, 1996
POWDER FREE VINYL EXAMINATION GLOVE
K964545 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 47d
Cleared Dec 30, 1996
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K964563 · LYY
Omni Sales Corp.
General Hospital · 46d
Cleared Dec 24, 1996
NEO-CARE DUAL LUMEN UMBILICAL CATHETER
K963972 · FOS
Klein-Baker Medical, Inc.
General Hospital · 82d
Cleared Dec 24, 1996
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE
K964060 · FMF
Travenol Laboratories (Israel) , Ltd.
General Hospital · 76d
Cleared Dec 23, 1996
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT...
K960982 · FMI
Sherwood Medical Co.
General Hospital · 287d
Cleared Dec 23, 1996
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
K962226 · FOZ
Johnson & Johnson Medical, Inc.
General Hospital · 196d
Cleared Dec 23, 1996
CONVERTORS DRAPE MATERIAL
K964125 · KKX
Allegiance Healthcare Corp.
General Hospital · 69d
Cleared Dec 23, 1996
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A
K964376 · LRJ
Mp Scientific, Inc.
General Hospital · 52d
Cleared Dec 20, 1996
CURITY THORACENTESIS TRAY
K964519 · GCX
Kendall Healthcare Products Co....
General Hospital · 38d
Cleared Dec 19, 1996
IRT LOCKING SYRINGE
K945410 · FMF
Interventional Research Technologies
General Hospital · 777d
Cleared Dec 19, 1996
SAFESKIN
K962139 · LZA
Safeskin Corp.
General Hospital · 199d
Cleared Dec 19, 1996
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
K962518 · LZA
P.T. Irama Dinamika Latex
General Hospital · 175d
Cleared Dec 19, 1996
PELVIC HOLDER
K963465 · FMQ
Deroyal Industries, Inc.
General Hospital · 107d
Cleared Dec 19, 1996
CHLOROPRENE EXAM GLOVES
K963771 · LZA
P.T. Irama Dinamika Latex
General Hospital · 91d
Cleared Dec 19, 1996
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT
K964828 · LRJ
S.C. Johnson & Son, Inc.
General Hospital · 17d
Cleared Dec 16, 1996
CELSITE PORT WITH PRECONNECTED CATHETER
K962230 · LJT
B.Braun Medical, Inc.
General Hospital · 189d
Cleared Dec 16, 1996
COVERAGE SPRAY HBV
K964835 · LRJ
Convatec, A Division of E.R. Squibb &...
General Hospital · 21d
Cleared Dec 13, 1996
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT
K964535 · LRJ
S.C. Johnson & Son, Inc.
General Hospital · 31d