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
76105–76128 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2002
UPLINK TEST SYSTEM
K020371 · DJG
OraSure Technologies, Inc.
Toxicology · 58d
Cleared Apr 03, 2002
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 51d
Cleared Apr 03, 2002
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
K020592 · DWL
Alba-Waldensian, Inc.
General Hospital · 40d
Cleared Apr 03, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
K020674 · MNH
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared Apr 03, 2002
EBI OMEGA21 SPINAL FIXATION SYSTEM
K020681 · MNH
Ebi, L.P.
Orthopedic · 30d
Cleared Apr 03, 2002
HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR
K020688 · HRX
Hydrocision, Inc.
Orthopedic · 30d
Cleared Apr 03, 2002
POWER TEK II
K020761 · HRX
Biomet, Inc.
Orthopedic · 27d
Cleared Apr 03, 2002
ADVANTA SST BIFURCATED GRAFT
K020767 · DSY
Atrium Medical Corp.
Cardiovascular · 26d
Cleared Apr 03, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · DLJ
Lin-Zhi International, Inc.
Toxicology · 27d
Cleared Apr 03, 2002
CT-C3000 SPIRAL CT SCANNER SYSTEM
K020913 · JAK
Neusoft Digital Medical Systems Co.,...
Radiology · 13d
Cleared Apr 03, 2002
SMARTSCORE 3.5
K020929 · JAK
GE Medical Systems
Radiology · 12d
Cleared Apr 03, 2002
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
K020935 · CGA
Hemocue, Inc.
Chemistry · 12d
Cleared Apr 02, 2002
MULTI HI-FLO PNEU, WISAP #7080
K011510 · HIF
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 321d
Cleared Apr 02, 2002
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710 · MYI
Oxoid , Ltd.
Microbiology · 302d
Cleared Apr 02, 2002
IMMUNE CELL FUNCTION ASSAY
K013169 · NID
Cylex, Inc.
Hematology · 193d
Cleared Apr 02, 2002
CROSSPOINT TRANSACCESS CATHETER
K013363 · ITX
Trans Vascular Incorporated
Radiology · 174d
Cleared Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · HWC
Arthrex, Inc.
Orthopedic · 85d
Cleared Apr 02, 2002
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL...
K020221 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 70d
Cleared Apr 02, 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 01, 2002
RE-USABLE STERILIZATION POUCH / BAG
K013715 · FRG
Quality Products of Montana
General Hospital · 144d
Cleared Apr 01, 2002
SIMPLICITY SIMPLEX SOFT INFUSION SET
K020629 · FPA
Sterling Medivations, Inc.
General Hospital · 34d
Cleared Mar 29, 2002
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F,...
K013779 · FLL
Mesure Technology
General Hospital · 136d
Cleared Mar 29, 2002
LIFEGUARD SAFETY INFUSION SET
K013871 · FPA
Horizon Medical Products, Inc.
General Hospital · 128d
Cleared Mar 29, 2002
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K014302 · MNH
Pisharodi Surgicals, Inc.
Orthopedic · 88d