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
63457–63480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2006
RX HERCULINK ELITE BILIARY STENT SYSTEM
K053454 · FGE
Guidant Corporation
Gastroenterology & Urology · 87d
Cleared Mar 06, 2006
ATHROCARE TOPAZ ARTHROWANDS
K053567 · HRX
Arthrocare Corp.
Orthopedic · 74d
Cleared Mar 06, 2006
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
K060009 · JDQ
Abbott Spine, Inc.
Orthopedic · 62d
Cleared Mar 06, 2006
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
K060224 · KRA
Cook Incorporated
Cardiovascular · 35d
Cleared Mar 06, 2006
XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM
K060361 · NKB
Stryker Spine
Orthopedic · 21d
Cleared Mar 06, 2006
EBI ANTERIOR CERVICAL PLATE SYSTEM
K060379 · KWQ
Ebi, L.P.
Orthopedic · 20d
Cleared Mar 03, 2006
ACUITY STEERABLE STYLET ACCESSORY
K053019 · DRB
Guidant Corporation
Cardiovascular · 128d
Cleared Mar 03, 2006
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · HKY
Medtronic Xomed, Inc.
Ophthalmic · 84d
Cleared Mar 03, 2006
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
K053450 · NHA
Atlantis Components, Inc.
Dental · 81d
Cleared Mar 03, 2006
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
K053475 · HMR
Refractec, Inc.
Ophthalmic · 79d
Cleared Mar 03, 2006
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
K053531 · CEC
Dade Behring, Inc.
Chemistry · 74d
Cleared Mar 03, 2006
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
K053564 · CAD
Penlon Limited
Anesthesiology · 71d
Cleared Mar 03, 2006
DOCTOR'S NIGHTGUARD
K053580 · MQC
Dental Concepts, LLC
Dental · 71d
Cleared Mar 03, 2006
FENIIIIIIX COLORATION KIT
K060086 · EIH
Dental Arte, Inc.
Dental · 51d
Cleared Mar 03, 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K060277 · JCX
Boehringer Laboratories
General & Plastic Surgery · 29d
Cleared Mar 03, 2006
KODAK MODELS 2100 AND 2200
K060292 · EHD
Kodak-Trophy
Radiology · 25d
Cleared Mar 02, 2006
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE...
K050975 · MMI
Nano-Ditech Co.
Chemistry · 318d
Cleared Mar 02, 2006
INNOCOR
K051907 · DQK
Innovision A/S
Cardiovascular · 231d
Cleared Mar 02, 2006
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K052623 · HAW
Medtronic Navigation, Inc.
Neurology · 160d
Cleared Mar 02, 2006
VYGON LATEX FREE BIONECTOR
K052881 · FOZ
Vygon Corp.
General Hospital · 141d
Cleared Mar 02, 2006
FIDIS VASCULITIS, MODEL MX007
K053012 · MOB
Biomedical Diagnostics (Bmd) SA
Immunology · 127d
Cleared Mar 02, 2006
PALOMAR LUXIR FRACTIONAL HANDPIECE
K060069 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 52d
Cleared Mar 02, 2006
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
K060209 · KWS
Tornier
Orthopedic · 34d
Cleared Mar 02, 2006
LC SPRINT NEBULIZER
K060399 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 15d