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
79105–79128 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2001
USS-LINE EXTENSION
K010108 · MNI
Synthes
Orthopedic · 145d
Cleared Jun 06, 2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193 · KFF
International Technidyne Corp.
Hematology · 135d
Cleared Jun 06, 2001
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
K010471 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 106d
Cleared Jun 06, 2001
SPARROWHAWK DISPOSABLE
K010473 · DWZ
Atc Technologies, Inc.
Cardiovascular · 106d
Cleared Jun 06, 2001
TBW
K010545 · NDL
Tri-Med, Inc.
Orthopedic · 103d
Cleared Jun 06, 2001
UNIQUE AMBULATORY EEG
K010697 · GWQ
Axon Systems, Inc.
Neurology · 90d
Cleared Jun 06, 2001
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN...
K010856 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 76d
Cleared Jun 06, 2001
TEMP-A-SURE
K010866 · FLL
Homecare Technologies , Ltd.
General Hospital · 76d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903 · MNI
Endius, Inc.
Orthopedic · 72d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · MNI
Endius, Inc.
Orthopedic · 71d
Cleared Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
K010953 · GKZ
Abbott Laboratories
Hematology · 68d
Cleared Jun 06, 2001
STA-LIATEST FREE PROTEIN S TEST KIT
K010963 · GGP
Diagnostica Stago, Inc.
Hematology · 68d
Cleared Jun 06, 2001
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
K011055 · FCM
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 61d
Cleared Jun 06, 2001
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
K011057 · PJD
OraSure Technologies, Inc.
Toxicology · 61d
Cleared Jun 06, 2001
TPO IGG ANTIBODY EIA TEST
K011082 · JZO
Scimedx Corp.
Immunology · 57d
Cleared Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K011390 · MBI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Jun 06, 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · MNI
Interpore Cross Intl.
Orthopedic · 27d
Cleared Jun 06, 2001
QED DIODE DETECTORS, MODELS 1112-1116
K011466 · LNH
Sun Nuclear Corp.
Radiology · 23d
Cleared Jun 06, 2001
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
K011485 · LNH
Fonar Corp.
Radiology · 22d
Cleared Jun 06, 2001
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528 · DLZ
Syva Co.
Chemistry · 20d
Cleared Jun 05, 2001
STRYKER PAINPUMP PCA
K003543 · FRN
Stryker Instruments
General Hospital · 200d
Cleared Jun 05, 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
K010429 · MMI
Beckman Coulter, Inc.
Chemistry · 112d
Cleared Jun 05, 2001
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K010682 · MUJ
Mds Nordion
Radiology · 90d
Cleared Jun 05, 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 89d