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
75481–75504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 2002
WOUND PROTECTOR/RETRACTOR
K020435 · KKX
Applied Medical Resources Corp.
General Hospital · 66d
Cleared Apr 15, 2002
CARESIDE TRGLYCERIDE
K020488 · CDT
Careside, Inc.
Chemistry · 61d
Cleared Apr 15, 2002
SYNTHES DUAL-OPENING USS
K020517 · MNI
Synthes (Usa)
Orthopedic · 55d
Cleared Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · GGC
Bio-Rad
Hematology · 28d
Cleared Apr 15, 2002
NBX - NON-BRIDGING EXTERNAL FIXATOR
K020905 · LXT
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Apr 12, 2002
LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
K011903 · DQK
Vivometrics, Inc.
Cardiovascular · 298d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
K012650 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
K012651 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10,...
K012654 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
K012657 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002
K020135 · GEI
Conmedcorp
General & Plastic Surgery · 87d
Cleared Apr 12, 2002
CONMED SYSTEM 5000 ESU
K020186 · GEI
Conmedcorp
General & Plastic Surgery · 84d
Cleared Apr 12, 2002
RPI SKIN OR AIR TEMPERATURE PROBE
K020219 · FMT
Replacement Parts Industries, Inc.
General Hospital · 80d
Cleared Apr 12, 2002
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
K020276 · NEU
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 74d
Cleared Apr 12, 2002
DENTITION INTEGRATING MATERIAL
K020287 · EBC
Pulpdent Corporation
Dental · 74d
Cleared Apr 12, 2002
DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)
K020330 · CAW
Pacific Consolidated Industries Llp
Anesthesiology · 71d
Cleared Apr 12, 2002
APC PLUS ADHESIVE
K020394 · DYH
3M Unitek
Dental · 65d
Cleared Apr 12, 2002
MITYVAC MERLIN, MODEL 10027
K020447 · HDB
Prism Enterprises, Inc.
Obstetrics & Gynecology · 60d
Cleared Apr 12, 2002
STATIC CRANIOPLASTY ORTHOSIS
K020448 · MVA
Eastern Cranial Affiliates
Neurology · 60d
Cleared Apr 12, 2002
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE...
K020496 · GKZ
Sysmex Corporation of America
Hematology · 57d
Cleared Apr 12, 2002
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS
K020575 · MRR
Elan Diagnostics
Chemistry · 50d
Cleared Apr 12, 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/...
K020662 · MMI
Ortho-Clinical Diagnostics
Chemistry · 42d
Cleared Apr 12, 2002
DEPILASE TWIN YAG LASER SYSTEM
K020697 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 39d
Cleared Apr 12, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K020809 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d