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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,808 results
12313–12336 of 17,808
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 13, 1991
INVOTEC EAR DRAPE
K911039 · KKX
Invotec International, Inc.
General Hospital · 66d
Cleared May 13, 1991
DISPOSABLE ISOLATION GOWN
K911921 · FYB
Liaoning-Usa Corp.
General Hospital · 13d
Cleared May 09, 1991
GRAVITY PLUS CONTROLLER/COMPOUNDER
K902853 · LHI
Fergy Corp.
General Hospital · 314d
Cleared May 09, 1991
RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM
K904237 · FPP
Innovative Medical Technologies, Inc.
General Hospital · 234d
Cleared May 09, 1991
PERRY(R) ENCORE CHEMOTHERAPY GLOVE
K911633 · LYY
Smith & Nephew Perry
General Hospital · 28d
Cleared May 07, 1991
DISPOSABLE RETRACTABLE NEEDLE SYRINGE
K910731 · FMF
Safe Tech Medical Products, Inc.
General Hospital · 76d
Cleared May 06, 1991
FREEDOM MARK III SURGICAL HELMET SYSTEM
K910515 · FYA
Stackhouse Assoc.
General Hospital · 90d
Cleared May 06, 1991
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
K910564 · FOZ
Menlo Care, Inc.
General Hospital · 87d
Cleared May 03, 1991
STATIM CASSETTE AUTOCLAVE
K910241 · FLE
Scican
General Hospital · 101d
Cleared May 03, 1991
MENTOR LUBRICATING JELLY
K910790 · KMJ
Mentor Corp.
General Hospital · 67d
Cleared May 03, 1991
SAFETY NEEDLE SHEATH, MODIFICATION
K911037 · FMI
Concord/Portex
General Hospital · 63d
Cleared May 03, 1991
ALADAN LATEX MEDICAL GLOVE
K911774 · LYY
Aladan Corp.
General Hospital · 14d
Cleared May 01, 1991
SERIM PERACETIC ACID REAGENT STRIPS
K910320 · JOJ
Serim Research Corp.
General Hospital · 97d
Cleared Apr 29, 1991
DISPOSAL PAD FOR SHARPS
K910516 · MMK
Visitec Co.
General Hospital · 83d
Cleared Apr 29, 1991
PIGGY LOCK NEEDLE HOUSING
K910546 · FPA
Icu Medical, Inc.
General Hospital · 82d
Cleared Apr 29, 1991
BARRIER* EXTRA PROTECTION PLUS FACE MASK
K910557 · FXX
Johnson & Johnson Medical, Inc.
General Hospital · 80d
Cleared Apr 29, 1991
INJECTION CAPS
K910572 · FOZ
Akcess Medical Products, Inc.
General Hospital · 77d
Cleared Apr 25, 1991
CONSUMER SENSORY PRODUCTS BIO-LOG 8000
K904955 · FLL
Consumer Sensory Products, Inc.
General Hospital · 171d
Cleared Apr 25, 1991
PHARM-ASSIST
K905116 · LHI
Excel Medical, Inc.
General Hospital · 163d
Cleared Apr 25, 1991
SPLASH GUARD
K905173 · KYZ
E.M. Adams
General Hospital · 160d
Cleared Apr 25, 1991
SURGICAL GOWNS, EXTRA-LARGE SIZE
K910410 · FYC
Dawn of Hope Development Center
General Hospital · 86d
Cleared Apr 25, 1991
PLASTIC (VINYL) EXAMINATION GLOVES
K910879 · LYZ
Siamount Plastic Corporation , Ltd.
General Hospital · 55d
Cleared Apr 25, 1991
EUDERMIC SURGICAL GLOVES
K911245 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 35d
Cleared Apr 25, 1991
PATIENT EXAMINATION LATEX GLOVES (NON-STERILE)
K911694 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 9d