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
60049–60072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2007
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
K070134 · BXN
Stockert GmbH
Anesthesiology · 65d
Cleared Mar 22, 2007
PAINT- ON POLISH AGENT
K070306 · EBD
Dentsply International, Inc.
Dental · 49d
Cleared Mar 22, 2007
BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L
K070485 · DXC
Cardiva Medical, Inc.
Cardiovascular · 30d
Cleared Mar 22, 2007
RUIKE 3421 POWERED WHEELCHAIR
K070501 · ITI
Shanghai Ruike Sports Goods Co., Ltd.
Physical Medicine · 29d
Cleared Mar 22, 2007
FISSO HOLDING SYSTEM
K070509 · GCJ
Baitella AG
General & Plastic Surgery · 28d
Cleared Mar 21, 2007
GENESIS DIODE LASER
K062258 · GEX
Ivoclar Vivadent, Inc.
General & Plastic Surgery · 229d
Cleared Mar 21, 2007
QUADRA BLOC TENS, MODEL 101
K062547 · GZJ
Gradient Technologies, LLC
Neurology · 203d
Cleared Mar 21, 2007
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
K063043 · FXX
Modern Healthcare Corp.
General Hospital · 169d
Cleared Mar 21, 2007
ADVANCE SPIKED POROUS TIBIAL BASE
K063128 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 159d
Cleared Mar 21, 2007
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
K063186 · LFX
Zeus Scientific, Inc.
Microbiology · 152d
Cleared Mar 21, 2007
HBA1C
K063209 · LCP
Thermo Electron OY
Chemistry · 149d
Cleared Mar 21, 2007
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND...
K063663 · DDG
Dade Behring, Inc.
Chemistry · 103d
Cleared Mar 21, 2007
MEMOMETAL FIXOS SCREWS
K070039 · HWC
Memometal Technologies
Orthopedic · 77d
Cleared Mar 21, 2007
ALIGN URETHRAL SUPPORT SYSTEM
K070073 · OTN
C.R. Bard, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 21, 2007
HASELMEIER PEN
K070100 · FMF
Haselmeier Sarl
General Hospital · 70d
Cleared Mar 21, 2007
PERFORMER CBP SYSTEM
K070213 · DTQ
Rand S.R.L.
Cardiovascular · 58d
Cleared Mar 21, 2007
CLEARFIL MAJESTY ESTHETIC PLT
K070325 · EBF
Kuraray Medical, Inc.
Dental · 44d
Cleared Mar 20, 2007
LMT-KATH-S
K062308 · FPA
Licher Medizintechnologie GmbH
General Hospital · 224d
Cleared Mar 20, 2007
SUNPOLAR HEALTHLINE, MODEL 100
K062873 · DWL
E.C.I. USA Corporation
General Hospital · 176d
Cleared Mar 20, 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
K062919 · LZA
Shen Wei (Usa), Inc.
General Hospital · 173d
Cleared Mar 20, 2007
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20,...
K063347 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 134d
Cleared Mar 20, 2007
CONICAL ANGLED ABUTMENT
K063403 · NHA
Implant Innovations, Inc.
Dental · 131d
Cleared Mar 20, 2007
TOTAL ETCH BONDING AGENT
K063444 · KLE
Dmg USA, Inc.
Dental · 125d
Cleared Mar 20, 2007
PERIPATCH ENDO-SLEEVE
K063556 · FTM
Pm Devices, Inc.
General & Plastic Surgery · 113d