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
39265–39288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2014
PANPAC WORD/BARTHOLIN CATHETER
K130087 · KNA
Panpac Medical Corporation
Obstetrics & Gynecology · 361d
Cleared Jan 10, 2014
CL10009 IR LASER
K130168 · ILY
Curae'Lase, Inc.
Physical Medicine · 351d
Cleared Jan 10, 2014
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
K130235 · NUN
Hans Biomed Corp.
Dental · 345d
Cleared Jan 10, 2014
ET PROSTHETIC SYSTEM
K130662 · NHA
Osstem Implant Co., Ltd.
Dental · 304d
Cleared Jan 10, 2014
BIOACTIVE BONE GRAFT PUTTY
K132071 · MQV
Biostructures, LLC
Orthopedic · 191d
Cleared Jan 10, 2014
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
K132076 · GIR
Dsrv, Inc.
Hematology · 191d
Cleared Jan 10, 2014
REAGENT, RUSSEL VIPER VENOM - LA SCREEN
K132130 · GIR
Dsrv, Inc.
Hematology · 184d
Cleared Jan 10, 2014
FUJIFILM 600 SERIES ENDOSCOPES
K132210 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 178d
Cleared Jan 10, 2014
ULTRASOUND SCANNER FLEX FOCUS 1202
K132335 · IYN
B-K Medical Aps
Radiology · 168d
Cleared Jan 10, 2014
ULTRASOUND SCANNER PRO FOCUS 2202
K132346 · IYO
B-K Medical Aps
Radiology · 165d
Cleared Jan 10, 2014
ANNEXTM ADJACENT LEVEL SYSTEM
K132403 · MNH
Spine Wave, Inc.
Orthopedic · 162d
Cleared Jan 10, 2014
NERVE CUFF
K132660 · JXI
Cook Biotech Incorporated
Neurology · 137d
Cleared Jan 10, 2014
DIGIFIX EXTERNAL FIXATION SYSTEM
K132731 · JEC
Virak Orthopedic Research, LLC
Orthopedic · 129d
Cleared Jan 10, 2014
PROBEAM PROTON THERAPY SYSTEM
K133191 · LHN
Varian Medical Systems
Radiology · 85d
Cleared Jan 10, 2014
FLEXMAP 3D
K133302 · NSU
Luminex Corp.
Pathology · 77d
Cleared Jan 10, 2014
AXIUM DETACHABLE COIL SYSTEM
K133310 · HCG
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 74d
Cleared Jan 10, 2014
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
K133604 · HBC
The Anspach Effort, Inc.
Neurology · 46d
Cleared Jan 09, 2014
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
K121235 · JEY
Stryker
Dental · 625d
Cleared Jan 09, 2014
CRYOLOCK
K122982 · MQK
Biotech, Inc.
Obstetrics & Gynecology · 470d
Cleared Jan 09, 2014
ACTIM PROM
K123986 · OAM
Alere Scarborough, Inc.
Chemistry · 379d
Cleared Jan 09, 2014
CASCADE HEMODIALYSIS/APHERESIS CATHETER
K130851 · MSD
Health Line International Corporation
Gastroenterology & Urology · 288d
Cleared Jan 09, 2014
SONOPULSE/ SONOPULSE III
K130888 · IMI
Ibramed- Industria Brazileria DE...
Physical Medicine · 286d
Cleared Jan 09, 2014
RX DAYTONA PLUS CHEMISTRY ANALYZER
K131554 · JJE
Randox Laboratories, Ltd.
Chemistry · 224d
Cleared Jan 09, 2014
BAUSCH & LOMB INJECTOR SYSTEM
K131958 · MSS
Bausch & Lomb
Ophthalmic · 196d