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

Filters: Cleared only ×
176,076 results
67849–67872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2004
BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
K041430 · BSZ
Blease Medical Equipment , Ltd.
Anesthesiology · 132d
Cleared Oct 07, 2004
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 98d
Cleared Oct 07, 2004
PANORAMIC 200A
K042001 · HLI
Optos Plc.
Ophthalmic · 73d
Cleared Oct 07, 2004
MAESTRO TOTAL WRIST
K042032 · JWJ
Biomet, Inc.
Orthopedic · 71d
Cleared Oct 07, 2004
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)
K042135 · HSB
Synthes (Usa)
Orthopedic · 59d
Cleared Oct 07, 2004
EXCELLA-M SPINAL SYSTEM
K042143 · KWP
Innovasis, Inc.
Orthopedic · 59d
Cleared Oct 07, 2004
CLEO 90 INFUSION SET
K042172 · FPA
Smiths Medical MD, Inc.
General Hospital · 57d
Cleared Oct 07, 2004
DIAZYME SODIUM ENZYMATIC ASSAY
K042189 · MZU
Diazyme Laboratories
Chemistry · 56d
Cleared Oct 07, 2004
NOVEL VBR SPINAL SYSTEM
K042201 · MQP
Alphatec/Nexmed
Orthopedic · 55d
Cleared Oct 07, 2004
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324 · JJY
Bio-Rad
Chemistry · 41d
Cleared Oct 07, 2004
PASCO MIC AND MIC/ID PANELS
K042331 · JWY
Pasco Laboratories, Inc.
Microbiology · 38d
Cleared Oct 07, 2004
TITANIUM TELEGRAPH HUMERAL NAIL
K042332 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 38d
Cleared Oct 07, 2004
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356 · HWC
Synthes (Usa)
Orthopedic · 37d
Cleared Oct 07, 2004
LOCON VLS DISTAL RADIUS PLATE SYSTEM
K042358 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 07, 2004
SYNTHES LOW PROFILE RECONSTRUCTION PLATES
K042377 · HRS
Synthes (Usa)
Orthopedic · 36d
Cleared Oct 07, 2004
VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
K042401 · IOR
American Track Roadsters, Inc.
Physical Medicine · 34d
Cleared Oct 07, 2004
IIIZAROV PULLEY SYSTEM
K042436 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 07, 2004
AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM
K042439 · GEX
Diamond Age Systems, Inc.
General & Plastic Surgery · 28d
Cleared Oct 07, 2004
ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
K042440 · HSB
Alphatec/Nexmed
Orthopedic · 28d
Cleared Oct 07, 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
K042458 · LXT
A.M. Surgical, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
VERTEX RECONSTRUCTION SYSTEM
K042498 · KWP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042499 · KWQ
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
K042508 · KWP
Depuy Spine, Inc.
Orthopedic · 22d