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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
91609–91632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 20, 1997
ANEUVYSION
K972200 · OYU
Vysis
Pathology · 132d
Cleared Oct 20, 1997
N-ASSAY TIA ANTITHROMBIN III TEST KIT
K972257 · DDQ
Crestat Diagnostics, Inc.
Hematology · 125d
Cleared Oct 20, 1997
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · JPA
Sigma Diagnostics, Inc.
Hematology · 125d
Cleared Oct 20, 1997
HEMAPROMPT
K972763 · KHE
Aerscher Diagnostics
Hematology · 88d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
K972779 · MRZ
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
K972780 · MRZ
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
N ANTISERUM TO HUMAN ALBUMIN
K972929 · DCF
Behring Diagnostics, Inc.
Immunology · 73d
Cleared Oct 20, 1997
QUANTA LITE B2 GPI IGA
K973006 · MSV
Inova Diagnostics, Inc.
Immunology · 68d
Cleared Oct 20, 1997
QUANTA LITE B2GPI IGM
K973014 · MSV
Inova Diagnostics, Inc.
Immunology · 68d