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
50377–50400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2010
CONMED MACROLYTE DISPERSIVE ELECTRODE
K100686 · GEI
Conmed Corporation
General & Plastic Surgery · 72d
Cleared May 21, 2010
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5
K100750 · JJX
Aalto Scientific, Ltd.
Microbiology · 66d
Cleared May 21, 2010
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032,...
K100769 · NRY
Penumbra, Inc.
Neurology · 64d
Cleared May 21, 2010
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X...
K100847 · KXK
Biocompatibles, Inc.
Radiology · 57d
Cleared May 21, 2010
SYNC-RX SYSTEM, MODEL AS00010
K100849 · IZI
Sync-Rx, Ltd.
Radiology · 56d
Cleared May 21, 2010
GUARDIAN II NC HEMOSTASIS VALVE
K101113 · DTL
Zerusa Limited
Cardiovascular · 30d
Cleared May 21, 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
K101139 · KNS
Medtronic, Inc.
Gastroenterology & Urology · 29d
Cleared May 20, 2010
ROYAL GUARD
K092617 · LZA
Shun Thai Rubber Gloves Industry...
General Hospital · 267d
Cleared May 20, 2010
ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET
K092628 · KNT
Alan Reid
Gastroenterology & Urology · 266d
Cleared May 20, 2010
MANUKAPLI WOUND DRESSING
K092689 · FRO
Manuka Medical Limited
General & Plastic Surgery · 260d
Cleared May 20, 2010
ALLY PLATFORM SYSTEM
K093895 · DRG
Continuity Health Solutions
Cardiovascular · 153d
Cleared May 20, 2010
OPTICAL INTEGRITY LASERGUARD FIBERS
K100194 · GEX
Optical Integrity, Inc.
General & Plastic Surgery · 118d
Cleared May 20, 2010
FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
K100365 · KNT
Corpak Medsystems
Gastroenterology & Urology · 97d
Cleared May 20, 2010
POWDER-FREE NITRILE GLOVES, BLACK
K100369 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 97d
Cleared May 20, 2010
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
K100616 · NDS
Life Technologies Corporation
Gastroenterology & Urology · 77d
Cleared May 20, 2010
LYMPHA PRESS 201MAX, MODEL 201MAX
K100677 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 71d
Cleared May 20, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100699 · LYZ
Shijiazhuang Star Plastic Co., Ltd.
General Hospital · 70d
Cleared May 20, 2010
DESARA MESH MODEL: CAL-DS01
K101169 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 24d
Cleared May 20, 2010
KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER
K101175 · MBI
Kfx Medical
Orthopedic · 23d
Cleared May 19, 2010
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
K083798 · MAX
Medicrea Technologies
Orthopedic · 513d
Cleared May 19, 2010
DISPOSABLE SUCTION AND IRRIGATION SYSTEM
K093479 · FHF
Modern Medical Equipment Mfg., Ltd.
Gastroenterology & Urology · 191d
Cleared May 19, 2010
SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115
K093820 · HWC
Memometal Technologies
Orthopedic · 156d
Cleared May 19, 2010
ADVIA CHEMISTRY SALICYLATE REAGENT
K093939 · DKJ
Siemens Healthcare Diagnostics
Chemistry · 148d
Cleared May 19, 2010
TERUMO LAUER LOCK ADAPTER
K093992 · DTL
Terumo Cardiovascular Systems...
Cardiovascular · 146d