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
51529–51552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2009
ARP RX100
K093259 · IPF
Arp Manufacturing, Inc.
Physical Medicine · 59d
Cleared Dec 17, 2009
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
K093397 · DQX
MicroVention, Inc.
Cardiovascular · 48d
Cleared Dec 17, 2009
SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
K093428 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d
Cleared Dec 17, 2009
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
K093546 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 30d
Cleared Dec 17, 2009
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
K093646 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Dec 16, 2009
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
K090964 · JWX
Binax, Inc.
Microbiology · 254d
Cleared Dec 16, 2009
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200,...
K090993 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 253d
Cleared Dec 16, 2009
AQUACEL AG SURGICAL
K091034 · FRO
Convatec
General & Plastic Surgery · 250d
Cleared Dec 16, 2009
FOOT AND HAND MOTION SYSTEM
K091118 · HWC
Newclip Technics
Orthopedic · 243d
Cleared Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
K091361 · LIP
Siemens Healthcare Diagnostics
Microbiology · 222d
Cleared Dec 16, 2009
ELECSYS PROBNP II CALCHECK 5
K092169 · JJX
Roche Diagnostics
Chemistry · 148d
Cleared Dec 16, 2009
E.COLI/P. AERUGINOSA PNA FISH
K092236 · JSS
Advandx, Inc.
Microbiology · 146d
Cleared Dec 16, 2009
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K092445 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 128d
Cleared Dec 16, 2009
STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV...
K092912 · EBF
Danville Materials, Inc.
Dental · 85d
Cleared Dec 16, 2009
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
K092928 · MUJ
Diversilabs, LLC
Radiology · 84d
Cleared Dec 16, 2009
ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
K093084 · EFB
Rolence Ent., Inc.
Dental · 76d
Cleared Dec 16, 2009
LOUSEBUSTER
K093144 · LJL
Larada Sciences
General Hospital · 72d
Cleared Dec 16, 2009
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
K093260 · MRN
International Biomedical, Ltd.
Anesthesiology · 58d
Cleared Dec 16, 2009
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
K093513 · NPJ
Conformis, Inc.
Orthopedic · 33d
Cleared Dec 16, 2009
MODIFICATION TO CASPIAN SPINAL SYSTEM
K093534 · KWP
K2m, Inc.
Orthopedic · 30d
Cleared Dec 16, 2009
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M...
K093549 · LZO
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Dec 15, 2009
CARIESCAN PRO
K090598 · NBL
Cariescan , Ltd.
Dental · 285d
Cleared Dec 15, 2009
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
K090785 · MWI
Invivo Corp.
Cardiovascular · 267d
Cleared Dec 15, 2009
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
K090931 · EKX
W&H Dentalwerk Buermoos GmbH
Dental · 257d