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
65689–65712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 2005
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
K051326 · HRX
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Jun 15, 2005
C.CAM-AC
K051460 · KPS
Danish Diagnostic Development A/S
Radiology · 12d
Cleared Jun 14, 2005
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
K043548 · KWQ
Blackstone Medical, Inc.
Orthopedic · 173d
Cleared Jun 14, 2005
FRIADENT ESTHETICAP
K050208 · NHA
Dentsply International
Dental · 137d
Cleared Jun 14, 2005
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
K050428 · LXM
Advanced Spinal Technologies, Inc.
Physical Medicine · 116d
Cleared Jun 14, 2005
CD HORIZON SPINAL SYSTEM
K050809 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 75d
Cleared Jun 14, 2005
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P,...
K050919 · DSI
Analogic Corp.
Cardiovascular · 63d
Cleared Jun 14, 2005
TRANS1 AXIALIF SYSTEM
K050965 · KWQ
Trans1 Incorporated
Orthopedic · 57d
Cleared Jun 14, 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW)
K051156 · LYZ
Shijiazhuang Manful Light Industrial...
General Hospital · 41d
Cleared Jun 14, 2005
REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K051220 · NLH
Sterilmed, Inc.
Cardiovascular · 33d
Cleared Jun 14, 2005
CONSTRUX MINI PEEK VBR SYSTEM
K051246 · MQP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Jun 14, 2005
CRANION CRANIAL FIXATION SYSTEM
K051293 · JEY
Ceremed , Inc.
Dental · 27d
Cleared Jun 13, 2005
SERIM DIALYSATE MONITOR TEST STRIP
K043031 · NTZ
Serim Research Corp.
Gastroenterology & Urology · 222d
Cleared Jun 13, 2005
GOODKNIGHT 425ST
K050072 · BZD
Nellcor Puritan Bennett, Inc.
Anesthesiology · 152d
Cleared Jun 13, 2005
ATRICURE ISOLATOR TRANSPOLAR PEN
K050459 · OCL
AtriCure, Inc.
Cardiovascular · 110d
Cleared Jun 13, 2005
SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
K050649 · FRO
Noble Fiber Technologies, Inc.
General & Plastic Surgery · 91d
Cleared Jun 13, 2005
QUANTA LITE SP100 ELISA
K050662 · NUM
Inova Diagnostics, Inc.
Immunology · 90d
Cleared Jun 13, 2005
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
K050673 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Jun 13, 2005
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
K050727 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 13, 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
K050733 · DJG
Lin-Zhi International, Inc.
Chemistry · 88d
Cleared Jun 13, 2005
PV 1900 SYNCHRO 0.016 GUIDEWIRE
K050964 · DQX
Boston Scientific - Precision Vascular
Cardiovascular · 56d
Cleared Jun 13, 2005
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
K051084 · DWM
Denver Biomedicals, Inc.
Anesthesiology · 46d
Cleared Jun 13, 2005
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K051265 · NBC
Bayer Healthcare, LLC
Chemistry · 28d
Cleared Jun 13, 2005
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
K051307 · JXM
Beckman Coulter, Inc.
Chemistry · 25d