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
54241–54264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2009
BIOACTYS
K082286 · LYC
Graftys
Dental · 197d
Cleared Feb 24, 2009
NEONATE HEAD AND BODY COILS
K083541 · MOS
Advanced Imaging Research, Inc.
Radiology · 88d
Cleared Feb 24, 2009
RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
K083645 · MQB
5 Star Medical, Inc.
Radiology · 77d
Cleared Feb 23, 2009
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
K080008 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 418d
Cleared Feb 23, 2009
DERMABLATE EFFECT
K081541 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 266d
Cleared Feb 23, 2009
RESOLUTIONMD, RELEASE 2.1
K082693 · LLZ
Calgary Scientific, Inc.
Radiology · 161d
Cleared Feb 23, 2009
NEO-STAT CO2
K083056 · CCK
Mercury Medical
Anesthesiology · 132d
Cleared Feb 23, 2009
PREMIUM SLOW SPEED
K083101 · EFB
Sable Industries, Inc.
Dental · 126d
Cleared Feb 23, 2009
SOLAS ANATOMIX SPINAL SYSTEM
K083178 · MNI
Biotechni America Spine Group, Inc.
Orthopedic · 118d
Cleared Feb 23, 2009
E.S TECK ( ELECTRO SENSOR TECK)
K083229 · MWI
Ld Technology, LLC
Cardiovascular · 112d
Cleared Feb 23, 2009
BIVONA TRACHEOSTOMY TUBES
K083641 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 76d
Cleared Feb 23, 2009
RETRACTOR LITE
K083710 · FST
Thomas Surgical Instruments, Inc.
General & Plastic Surgery · 70d
Cleared Feb 23, 2009
.035 LOC GUIDE WIRE EXTENSION
K083713 · DQX
Abbott Vascular
Cardiovascular · 70d
Cleared Feb 23, 2009
GLUSEAL 90, MODEL GLU9010
K083752 · KMF
Glustitch, Inc.
General & Plastic Surgery · 68d
Cleared Feb 23, 2009
INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING...
K083879 · BZG
Innovision A/S
Anesthesiology · 56d
Cleared Feb 23, 2009
CHROMOPHARE E 668
K090378 · FSY
Berchtold GmbH & Co. KG
General & Plastic Surgery · 6d
Cleared Feb 20, 2009
TRANSITION STABILIZATION SYSTEM
K073439 · NQP
Globus Medical, Inc.
Orthopedic · 441d
Cleared Feb 20, 2009
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN...
K080481 · DDR
Beckman Coulter, Inc.
Chemistry · 364d
Cleared Feb 20, 2009
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
K080853 · NBW
Genexel-Sein, Inc.
Chemistry · 331d
Cleared Feb 20, 2009
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST...
K080874 · CIX
Medica Corp.
Chemistry · 326d
Cleared Feb 20, 2009
SCRAMBLER ST 5 TENS DEVICE
K081255 · GZJ
Competitive Technologies,Inc.
Neurology · 294d
Cleared Feb 20, 2009
FANNING-PAPPAS MODULAR KNEE BEARING
K081400 · JWH
Endotec, Inc.
Orthopedic · 277d
Cleared Feb 20, 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K081419 · DZE
Institut Straumann AG
Dental · 276d
Cleared Feb 20, 2009
ADVANCE A-CLASS TIBIAL INSERT
K081479 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 269d