Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
76609–76632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
K020817 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 30d
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS...
K020824 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Apr 12, 2002
EFILM WORKSTATION WITH MODULES
K020995 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Apr 12, 2002
ABP-2000 G-3
K021029 · DXN
Biotrac, Inc.
Cardiovascular · 14d
Cleared Apr 11, 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 601d
Cleared Apr 11, 2002
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
K011068 · KTL
Rhigene, Inc.
Immunology · 367d
Cleared Apr 11, 2002
ZOLL PAD WITH CPR AID
K011541 · MKJ
Zoll Medical Corp
Cardiovascular · 328d