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

Filters: Cleared only ×
175,820 results
45601–45624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2011
ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES
K102921 · GEI
Bema-GmbH & Co. KG
General & Plastic Surgery · 445d
Cleared Dec 20, 2011
KIM
K103022 · OTN
Neomedic International S.L.
Gastroenterology & Urology · 434d
Cleared Dec 20, 2011
UNMIAX LAPAROSCOPIC INSTRUMENT
K103508 · GEI
Unimax Medical Systems, Inc.
General & Plastic Surgery · 386d
Cleared Dec 20, 2011
METRON-CP/MD
K103554 · LLZ
Eponatech, LLC
Radiology · 382d
Cleared Dec 20, 2011
MICHELE SLEEP SCORING SYSTEMS
K112102 · MNR
Younes Sleep Technologies
Anesthesiology · 151d
Cleared Dec 20, 2011
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
K112430 · KHP
Abbott Pont of Care, Inc.
Chemistry · 118d
Cleared Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL...
K112941 · JWH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 20, 2011
PDS(TM) BARBED SUTURES
K113004 · NEW
Ethicon, Inc.
General & Plastic Surgery · 74d
Cleared Dec 20, 2011
MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
K113028 · HRX
Medisiss
Orthopedic · 70d
Cleared Dec 20, 2011
DIRECT ANTIBIOTIC INFUSION KIT
K113043 · LJS
Summit Medical Products, Inc.
General & Plastic Surgery · 68d
Cleared Dec 20, 2011
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
K113136 · LLZ
Totoku Electric Co., Ltd.
Radiology · 57d
Cleared Dec 20, 2011
IFS SUBTALAR IMPLANT
K113399 · HWC
Internal Fixation Systems, Inc.
Orthopedic · 33d
Cleared Dec 20, 2011
ELM PTA BALLON DILATATION CATHETER
K113468 · LIT
Creagh Medical, Ltd.
Cardiovascular · 28d
Cleared Dec 20, 2011
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
K113523 · PHX
Lima Corporate S.P.A.
Orthopedic · 21d
Cleared Dec 20, 2011
CLYDESDALE(R) SPINAL SYSTEM
K113528 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Dec 20, 2011
HEALIX KNOTLESS ANCHOR
K113534 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 20d
Cleared Dec 20, 2011
POWER-LOAD COT FASTENER SYSTEM
K113598 · FPO
Stryker Medical
General Hospital · 15d
Cleared Dec 19, 2011
NOFACT VIII
K102851 · GJT
R2 Diagnostics, Inc.
Hematology · 446d
Cleared Dec 19, 2011
NOFACT IX
K102908 · GJT
R2 Diagnostics, Inc.
Hematology · 444d
Cleared Dec 19, 2011
ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
K110895 · HWC
Ortho Solutions Limited
Orthopedic · 264d
Cleared Dec 19, 2011
ACEM
K111013 · FFZ
Sandhill Scientific, Inc.
Gastroenterology & Urology · 252d
Cleared Dec 19, 2011
MX-7000 MICROXEL
K111831 · ONG
Bio-Med USA, Inc.
General & Plastic Surgery · 174d
Cleared Dec 19, 2011
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45...
K112056 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 153d
Cleared Dec 19, 2011
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
K112443 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 117d