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
82849–82872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2000
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND...
K000892 · OLT
Datex-Ohmeda, Inc.
Neurology · 88d
Cleared Jun 16, 2000
ULTRASTIM ELECTRODE, MODEL US4040
K000947 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 85d
Cleared Jun 16, 2000
PLACER MODEL 6232 STEERABLE STYLET
K000955 · DRB
Medtronic Vascular
Cardiovascular · 84d
Cleared Jun 16, 2000
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
K000972 · LXT
Synthes (Usa)
Orthopedic · 81d
Cleared Jun 16, 2000
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
K000996 · EFT
Dentsply Intl.
Dental · 80d
Cleared Jun 16, 2000
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
K001463 · EBI
Davis Schottlander & Davis, Ltd.
Dental · 37d
Cleared Jun 16, 2000
DYNA-LOK CLASSIC SPINAL SYSTEM
K001532 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Jun 16, 2000
ECHOCOM, IMAGECOM, DOKUCOM
K001592 · DQK
Tomtec Imaging Systems GmbH
Cardiovascular · 24d
Cleared Jun 15, 2000
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
K001039 · LPH
Implex Corp.
Orthopedic · 76d
Cleared Jun 15, 2000
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
K001082 · FYD
Stackhouse, Inc.
General Hospital · 72d
Cleared Jun 15, 2000
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
K001084 · LXT
Immedica, Inc.
Orthopedic · 72d
Cleared Jun 15, 2000
PIPET CURET
K001545 · HHK
Milex Products, Inc.
Obstetrics & Gynecology · 28d
Cleared Jun 15, 2000
MACH 7
K990060 · KOJ
Kreativ, Inc.
Dental · 524d
Cleared Jun 15, 2000
STERRAD 100S STERILIZER
K991999 · MLR
Advanced Sterilization Products
General Hospital · 367d
Cleared Jun 14, 2000
AC POWERED THERMAL CAUTERY UNIT
K000893 · HQO
Starion Instruments
Ophthalmic · 86d
Cleared Jun 14, 2000
NBS CONNECTING TUBE SET
K001068 · HIF
Nbs Products CO
Obstetrics & Gynecology · 72d
Cleared Jun 14, 2000
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
K001112 · DXJ
General Electric Medical Systems...
Cardiovascular · 69d
Cleared Jun 14, 2000
THERMAL CAUTERY FORCEPS
K001262 · GEI
Starion Instruments
General & Plastic Surgery · 56d
Cleared Jun 14, 2000
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
K001273 · GEI
Starion Instruments
General & Plastic Surgery · 55d
Cleared Jun 14, 2000
MICROPERFORATION INSTRUMENT
K001507 · LXH
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Jun 14, 2000
MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE...
K001593 · GEI
Chester Labs, Inc.
General & Plastic Surgery · 22d
Cleared Jun 14, 2000
MALLORY HEAD MODULAR CALCAR
K001660 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Jun 14, 2000
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
K001713 · MOS
Mri Devices Corp.
Radiology · 9d
Cleared Jun 14, 2000
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
K994209 · DWF
Cobe Cardiovascular, Inc.
Cardiovascular · 183d