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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
50233–50256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2010
UNIMOM ALLEGRO
K100929 · HGX
Blue Egg CO
Obstetrics & Gynecology · 72d
Cleared Jun 16, 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
K101119 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 56d
Cleared Jun 16, 2010
ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
K101406 · QEZ
Medrad Interventional/Possis
Cardiovascular · 28d
Cleared Jun 15, 2010
VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
K092107 · MQL
Nidacon International AB
Obstetrics & Gynecology · 336d
Cleared Jun 15, 2010
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21,...
K092638 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 292d
Cleared Jun 15, 2010
OUCHLESS MODEL PN10114
K093951 · MLY
Occam Design
Physical Medicine · 174d
Cleared Jun 15, 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES...
K101421 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Jun 14, 2010
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
K082102 · FED
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 689d
Cleared Jun 14, 2010
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA...
K090608 · GXI
Minta Medical Limited
Neurology · 465d
Cleared Jun 14, 2010
HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI
K094009 · GEI
Halt Medical, Inc.
General & Plastic Surgery · 168d
Cleared Jun 14, 2010
ORAL/ENTERAL SYRINGES
K100099 · FPD
Philips Children'S Medical Ventures
Gastroenterology & Urology · 152d
Cleared Jun 14, 2010
SUDOSCAN
K100233 · GZO
Impeto Medical
Neurology · 139d
Cleared Jun 14, 2010
MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY
K100366 · KNT
Maxter Catheters
Gastroenterology & Urology · 122d
Cleared Jun 14, 2010
OTIS -C PLUS
K100604 · HRS
Sciences ET Bio Materiaux (Sbm)
Orthopedic · 103d
Cleared Jun 14, 2010
TIDI FACEMASK
K100800 · FXX
Tidi Products,Llc
General Hospital · 84d
Cleared Jun 14, 2010
UNITED STEM, PSA TYPE
K100981 · JWH
United Orthopedic Corp.
Orthopedic · 66d
Cleared Jun 14, 2010
CRYOCARE CS SURGICAL SYSTEM
K101333 · GEH
Endocare, Inc.
General & Plastic Surgery · 33d
Cleared Jun 14, 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES
K101341 · LYZ
Shijiazhuang Universal Channel...
General Hospital · 33d
Cleared Jun 14, 2010
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
K101444 · GDW
Surgical Devices, A Global Business...
General & Plastic Surgery · 21d
Cleared Jun 14, 2010
BD DIRECTIGEN EZ FLU A+B ASSAY
K101529 · PSZ
Becton, Dickinson & CO
Microbiology · 12d
Cleared Jun 11, 2010
INRATIO/INRATIO2 TEST STRIPS
K092987 · GJS
Biosite Incorporated
Hematology · 256d
Cleared Jun 11, 2010
BRAINLAB KNEE ARTHROSCOPY
K093118 · OLO
Brainlab AG
Orthopedic · 252d
Cleared Jun 11, 2010
PASR/QUIETNITE
K093340 · LRK
Exact Supplies , Ltd.
Dental · 228d
Cleared Jun 11, 2010
THE WATER LILY
K094022 · KPL
Clearwater Products, LLC
Gastroenterology & Urology · 163d