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
76849–76872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · MEB
I-Flow Corp.
General Hospital · 19d
Cleared Mar 20, 2002
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
K020777 · MNS
Respironics, Inc.
Anesthesiology · 9d
Cleared Mar 19, 2002
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01
K010253 · DYG
Transonic Systems, Inc.
Cardiovascular · 417d
Cleared Mar 19, 2002
HEARTTRENDS
K012825 · DQK
Lev-El, Ltd.
Cardiovascular · 208d
Cleared Mar 19, 2002
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · HIR
Hollister, Inc.
Gastroenterology & Urology · 134d
Cleared Mar 19, 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · GEI
Aesculap, Inc.
General & Plastic Surgery · 89d
Cleared Mar 19, 2002
KAYAK HYDROPHILIC GUIDE WIRES
K014195 · DOX
Boston Scientific Corp
Toxicology · 88d
Cleared Mar 19, 2002
SULZER DENTAL CERAMIC SYSTEM-SPLINE
K014214 · DZE
Sulzer Dental, Inc.
Dental · 88d
Cleared Mar 19, 2002
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
K020237 · JJY
Consolidated Technology
Chemistry · 55d
Cleared Mar 19, 2002
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
K020500 · SCL
Univec, Inc.
General Hospital · 33d
Cleared Mar 19, 2002
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
K020526 · FHN
Don Wilson/Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 18, 2002
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
K013201 · GEX
Cardiofocus, Inc.
General & Plastic Surgery · 174d
Cleared Mar 18, 2002
PAEDISCOPE, MODEL # P010A AND PF011A
K014149 · GWG
Aesculap, Inc.
Neurology · 90d
Cleared Mar 18, 2002
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09
K014154 · HWC
Vilex, Inc.
Orthopedic · 90d
Cleared Mar 18, 2002
OPENING/CLOSING WEDGE OSTETOMY PLATES
K014155 · HRS
Arthrex, Inc.
Orthopedic · 89d
Cleared Mar 18, 2002
CERASORB ORTHO
K014156 · MQV
Curasan AG
Orthopedic · 89d
Cleared Mar 18, 2002
FORTAFLEX SURGICAL MESH
K020049 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 70d
Cleared Mar 18, 2002
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED...
K020069 · HBB
Medtronic Midas Rex
Neurology · 68d
Cleared Mar 18, 2002
CONVERTORS SMS POLYOLEFIN GOWN
K020593 · FYA
Allegiance Healthcare Corp.
General Hospital · 24d
Cleared Mar 15, 2002
AUTODIMER ASSAY MODEL # 1431
K012755 · DAP
Xtrana, Inc.
Hematology · 211d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012778 · JWH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012787 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE...
K012788 · KWS
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
XIVE DENTAL IMPLANT SYSTEM
K013867 · DZE
Friadent GmbH
Dental · 114d