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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
174313–174336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1976
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
K761194 · DRM
Mckesson Corp.
Cardiovascular · 3d
Cleared Dec 09, 1976
ESOPHAGEAL OBTURATION AIRWAY
K761195 · CAO
Mckesson Corp.
Anesthesiology · 3d
Cleared Dec 09, 1976
MODEL 3044 3-CHANNEL STRESS TEST SYSTEM
K761198 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 3d
Cleared Dec 09, 1976
AQUA-SEAL
K761202 · KDQ
Respiratory Care, Inc.
General Hospital · 2d
Cleared Dec 09, 1976
TAXO DISCS FOR DIFF. OF ANAEROBES
K761209 · JTO
Bioquest
Microbiology · 2d
Cleared Dec 06, 1976
LITHOTRITE
K760273 · FGK
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 137d
Cleared Dec 06, 1976
RADIO IMMUNO ASSAY KIT/
K760619 · CDD
New England Nuclear
Chemistry · 84d
Cleared Dec 06, 1976
ADAPTER, FIBER OPTICS HEADLIGHT
K760647 · FCW
Pilling Co.
Gastroenterology & Urology · 82d
Cleared Dec 06, 1976
ADAPTER/STANDARD FIBER OPTICS LIGHT
K760653 · EQH
Pilling Co.
Ear, Nose, Throat · 81d
Cleared Dec 06, 1976
MULTI-PORTED FACE PLATE
K760654
Pilling Co.
Cardiovascular · 81d
Cleared Dec 06, 1976
DONORMATIC (BLOOD COLLECTION DEVICE)
K760743 · KSQ
Lifeline Instruments, Inc.
Hematology · 67d
Cleared Dec 06, 1976
TRIEX-1 HOLLOW FIBER DIALYZER
K760781 · FJT
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 62d
Cleared Dec 06, 1976
RUTNER UNIVERSAL WEDGE CATHETER
K760858 · KOD
Cook, Inc.
Gastroenterology & Urology · 49d
Cleared Dec 06, 1976
BEDSIDE CONSOLES (11-3-910 & 11-3-930)
K760965 · FKQ
Seattle Artificial Kidney Supply Co.
Gastroenterology & Urology · 32d
Cleared Dec 06, 1976
PAP-TRAY I (CATALOG #C600-1)
K761000 · LEA
Lerner Laboratories, Inc.
Pathology · 28d
Cleared Dec 06, 1976
PAP-TRAY II (CATALOG #C600-2)
K761001 · LEA
Lerner Laboratories, Inc.
Pathology · 28d
Cleared Dec 06, 1976
CARDIART 108T/313
K761014 · DPS
Conway Electronic Enterprises , Ltd.
Cardiovascular · 27d
Cleared Dec 06, 1976
SINGLE NEEDLE HEMODIALYSIS
K761038 · KOC
Sorensen Research
Gastroenterology & Urology · 21d
Cleared Dec 06, 1976
HEMO-CATH I, KIDNEY DIALYSIS CATHETER
K761078 · KOC
Medical Disposables Intl., Inc.
Gastroenterology & Urology · 17d
Cleared Dec 06, 1976
SINGLE NEEDLE HEMODIALYSIS (BFC-161)
K761081 · KOC
Sorensen Research
Gastroenterology & Urology · 17d
Cleared Dec 06, 1976
SINGLE NEEDLE HEMODIALYSIS (BFC-142)
K761082 · KOC
Sorensen Research
Gastroenterology & Urology · 17d
Cleared Dec 06, 1976
ELECTRONIC CONTROL UNIT
K761087 · DWJ
Gorman Rupp Industries
Cardiovascular · 14d
Cleared Dec 06, 1976
MULTI-CELL ULTRAFILTRATION SYSTEM
K761100 · JQQ
Amicon, Inc.
Chemistry · 13d
Cleared Dec 06, 1976
FEM CATH (URETHRAL CATHETER)
K761144 · KOD
Mallinckrodt Critical Care
Gastroenterology & Urology · 10d