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
44305–44328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT May 22, 2012
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
K120533 · PDU
Bridgepoint Medical
Cardiovascular · 90d
Cleared May 22, 2012
CELL SAVER ELITE
K120586 · CAC
Haemonetics Corp.
Anesthesiology · 85d
Cleared May 22, 2012
TAPER SET HIP SYSTEM RDP STEM
K121263 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 26d
Cleared May 22, 2012
AMPHIRION PLUS PTA CATHETER
K121265 · LIT
Medtronic, Inc.
Cardiovascular · 26d
Cleared May 21, 2012
VISIONSEARCH 1
K120104 · GWE
Visionsearch Pty, Ltd.
Neurology · 129d
Cleared May 21, 2012
FALLER TROCAR
K120130 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 125d
Cleared May 21, 2012
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
K120404 · ELM
Merz Dental GmbH
Dental · 102d
Cleared May 21, 2012
DYNA LOCKING ANKLE NAIL
K120419 · HSB
U&I Corp.
Orthopedic · 101d
Cleared May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495 · DQO
Boston Scientific Corp
Cardiovascular · 94d
Cleared May 21, 2012
ORTHODONTIC FLOWABLE BRACKET ADHESIVE
K120619 · DYH
Novocol, Inc.
Dental · 82d
Cleared CT May 18, 2012
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K111450 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 359d
Cleared May 18, 2012
LEFORTE SYSTEM BONE PLATE & SCREW
K112457 · JEY
Arkin Consulting Group
Dental · 266d
Cleared May 18, 2012
CONCENTRIC BALLOON GOOGLE
K112698 · ODC
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 245d
Cleared May 18, 2012
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
K113271 · KWA
Biomet Manufacturing, Inc.
Orthopedic · 196d
Cleared May 18, 2012
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX...
K113565 · FOZ
Edwards Lifesciences, LLC
General Hospital · 168d
Cleared May 18, 2012
DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM
K113576 · CBI
Etview , Ltd.
Anesthesiology · 165d
Cleared May 18, 2012
ORION II CT CVC
K113622 · FOZ
Health Line International Corporation...
General Hospital · 162d
Cleared May 18, 2012
R&D INNOVATION PEDICLE SCREW SYSTEM
K120091 · NKB
R&D Innovation, LLC
Orthopedic · 128d
Cleared May 18, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099 · MNI
K2m, Inc.
Orthopedic · 127d
Cleared CT May 18, 2012
SRS ENDOSCOPIC STAPLING SYSTEM
K120299 · ODE
Medigus , Ltd.
Gastroenterology & Urology · 108d
Cleared May 18, 2012
PERMACOL SURGICAL IMPLANT
K120605 · FTM
Covidien, LLC
General & Plastic Surgery · 80d
Cleared May 18, 2012
GENESIS II PS NON-MODULAR FEMORAL COMPONENT
K120698 · JWH
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared May 18, 2012
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
K120911 · OQW
Cepheid
Microbiology · 53d
Cleared May 18, 2012
SYNTHES MATRIX SYSTEM
K120928 · NKB
Synthes Spine
Orthopedic · 52d