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: Cleared only ×
175,468 results
89737–89760 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1998
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972849 · FXX
Cypress Medical Products, Ltd.
General Hospital · 300d
Cleared May 28, 1998
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001,...
K974285 · DPW
Perimed, Inc.
Cardiovascular · 195d
Cleared May 28, 1998
ETEST OFLOXACIN
K980338 · JWY
Ab Biodisk
Microbiology · 120d
Cleared May 28, 1998
SURGISIS
K980431 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 113d
Cleared May 28, 1998
PAINBUSTER INFUSION SYSTEM
K980558 · MEB
I-Flow Corp.
General Hospital · 104d
Cleared May 28, 1998
LYSONIX LIPOPLASTY ACCESS PORT
K980763 · QPB
Lysonix, Inc.
General & Plastic Surgery · 90d
Cleared May 28, 1998
CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01,...
K980961 · DRF
Cordis Webster, Inc.
Cardiovascular · 73d
Cleared May 28, 1998
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
K980992 · FPA
Venetec Intl., Inc.
General Hospital · 72d
Cleared May 28, 1998
AIA-PACK MYOGLOBIN ASSAY
K981012 · DDR
Tosoh Medics, Inc.
Immunology · 71d
Cleared May 28, 1998
ETEST TETRACYCLINE
K981134 · JWY
Ab Biodisk
Microbiology · 59d
Cleared May 28, 1998
LICEMEISTER COMB
K981250 · LJL
National Pediculosis Assoc.
General Hospital · 52d
Cleared May 28, 1998
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005...
K981512 · JHI
Skd, Inc. A Beckman Coulter Co.
Chemistry · 30d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
K981584 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 27, 1998
MANAN NEPHROSTOMY DRAINAGE CATHETER
K980192 · LJE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 127d
Cleared May 27, 1998
MANAN GENERAL UTILITY DRAINAGE CATHETER
K980193 · LJE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 127d
Cleared May 27, 1998
ETEST CEFTRIAXONE
K980345 · JWY
Ab Biodisk
Microbiology · 118d
Cleared May 27, 1998
ETEST TETRACYCLINE
K980347 · JWY
Ab Biodisk
Microbiology · 119d
Cleared May 27, 1998
HOPE NEBULIZER
K980407 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 113d
Cleared May 27, 1998
OSTEONICS ANTEVERTED NECK HA HIP STEMS
K980766 · MEH
Osteonics Corp.
Orthopedic · 89d
Cleared May 27, 1998
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV...
K980917 · GCA
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 77d
Cleared May 27, 1998
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
K980989 · KMF
Innovative Technologies , Ltd.
General & Plastic Surgery · 72d
Cleared May 27, 1998
SIMAL CERVICAL STABILIZATION SYSTEM
K981008 · KWQ
Top Surgical Products GmbH
Orthopedic · 70d
Cleared May 27, 1998
ALKPHASE-B ASSAY KIT
K981373 · CIN
Metra Biosystems, Inc.
Chemistry · 41d