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
92113–92136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1997
BOVIE MODEL X40
K972071 · GEI
Maxxim Medical
General & Plastic Surgery · 140d
Cleared Oct 21, 1997
REGENESIS MODEL 42
K972093 · ILX
Regenesis Biomedical, Inc.
Physical Medicine · 139d
Cleared Oct 21, 1997
DIGIFLEX SURGICAL GLOVES
K972277 · KGO
Hms Services, Inc.
General Hospital · 125d
Cleared Oct 21, 1997
AUTO-LYTE COTININE EIA
K972481 · MKU
OraSure Technologies, Inc.
Toxicology · 111d
Cleared Oct 21, 1997
TITANIUM HEMOSTATIC CLIP
K972745 · MCH
Eisner USA, Inc.
General & Plastic Surgery · 90d
Cleared Oct 21, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
K972746 · DPS
Alexander Mfg. Co.
Cardiovascular · 90d
Cleared Oct 21, 1997
DURACON CONVERSION METAL BACKED PATELLA
K972752 · JWH
Howmedica Corp.
Orthopedic · 90d
Cleared Oct 21, 1997
NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER
K972765 · GEX
American Laser Medical
General & Plastic Surgery · 89d
Cleared Oct 21, 1997
ADVANCE ULTRA-CONGRUENT TIBIAL INSERT
K972770 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 89d
Cleared Oct 21, 1997
ALLIANCE RUBBER, EC-GRIP
K972801 · LYY
Alliance Rubber Products Sdn. Bhd.
General Hospital · 85d
Cleared Oct 21, 1997
PROVISION SURGICAL HELMET SYSTEM
K972832 · FYA
Depuy, Inc.
General Hospital · 83d
Cleared Oct 21, 1997
NPB-290 PULSE OXIMETER (NPB-290)
K972837 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 82d
Cleared Oct 21, 1997
VISTA BRITE TIP GUIDING CATHETERS
K972978 · DQY
Cordis Corp.
Cardiovascular · 71d
Cleared Oct 21, 1997
LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC...
K973110 · GEI
Ludlow Technical Products
General & Plastic Surgery · 62d
Cleared Oct 21, 1997
HYDRASORB STERILE DRESSING
K973260 · MGP
Avitar, Inc.
General & Plastic Surgery · 53d
Cleared Oct 21, 1997
ALGINATE/ZINC WOUND DRESSING
K973283 · KMF
Innovative Technologies , Ltd.
General & Plastic Surgery · 49d
Cleared Oct 21, 1997
HYDROFLEX
K973343 · ELW
GC America, Inc.
Dental · 46d
Cleared Oct 21, 1997
DENTALVIEW PERIOVIEW SYSTEM
K973492 · EIA
Dentalview, Inc.
Dental · 36d
Cleared Oct 21, 1997
KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
K973572 · MDA
Hanson Medical, Inc.
General & Plastic Surgery · 32d
Cleared Oct 21, 1997
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)
K973811 · LYY
Absolute Quality Leadership, Inc.
General Hospital · 14d
Cleared Oct 20, 1997
VENTANA CD45 PRIMARY ANTIBODY
K940583 · DEH
Ventana Medical Systems, Inc.
Immunology · 1350d
Cleared Oct 20, 1997
ULTRASOUND TRANSDUCER DRAPE
K970889 · KKX
Protek Medical Products, Inc.
General Hospital · 223d
Cleared Oct 20, 1997
ULTRASOUND TRANSDUCER DRAPE
K970893 · FYA
Protek Medical Products, Inc.
General Hospital · 223d
Cleared Oct 20, 1997
N-ASSAY TIA PLASMINOGEN TEST KIT
K971985 · GGP
Crestat Diagnostics, Inc.
Hematology · 144d