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
75097–75120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2002
XLTEK SLEEP SYSTEM
K022037 · OLV
Excel Tech. , Ltd.
Neurology · 78d
Cleared Sep 10, 2002
DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB...
K022104 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 74d
Cleared Sep 10, 2002
AVAGEN WOUND DRESSING
K022127 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 71d
Cleared Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP...
K022158 · CGA
Instrumentation Laboratory CO
Chemistry · 70d
Cleared Sep 10, 2002
NORMED MINI EXTERNAL FIXATOR SYSTEM
K022230 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 10, 2002
PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
K022664 · GAM
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 32d
Cleared Sep 10, 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K022782 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 19d
Cleared Sep 09, 2002
ACT III VENTRICULAR CATHETER
K013705 · GWM
Innerspace, Inc.
Neurology · 305d
Cleared Sep 09, 2002
IPLAN
K020631 · HAW
Brainlab AG
Neurology · 194d
Cleared Sep 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972 · DHR
Wako Chemicals USA, Inc.
Immunology · 167d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218 · JFT
Roche Diagnostics Corp.
Chemistry · 145d
Cleared Sep 09, 2002
P4 PHYSIO
K022175 · IPF
Valmed Corp.
Physical Medicine · 68d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM...
K022182 · NBW
Abbott Laboratories
Chemistry · 68d
Cleared Sep 09, 2002
CRANIAL SYMMETRY SYSTEM
K022273 · MVA
Beverly Hills Prosthetics Orthotics,...
Neurology · 56d
Cleared Sep 09, 2002
NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
K022323 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
K022325 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
BENJAMIN ENVOY PHACO HANDPIECE
K022833 · HQC
Benjamin Biomedical, Inc.
Ophthalmic · 14d
Cleared Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · MQV
Biomet, Inc.
Orthopedic · 477d
Cleared Sep 06, 2002
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345 · KWS
Arthrex, Inc.
Orthopedic · 217d
Cleared Sep 06, 2002
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
K021278 · ODG
Pentax Precision Instrument Corp.
Radiology · 137d
Cleared Sep 06, 2002
G-2 VERSION 3, MODEL 10049
K021890 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
G-MOPS, MODEL 10030
K021893 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
G-MM, MODEL 10038
K021894 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
HSA-SOLUTION, MODEL 10034/10064
K021896 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d