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
79393–79416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2001
AMIGO WHEELCHAIR
K010503 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 135d
Cleared Jul 06, 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Jul 06, 2001
CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
K011243 · LSB
Chattanooga Group, Inc.
Physical Medicine · 74d
Cleared Jul 06, 2001
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
K011787 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 05, 2001
TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS
K003818 · DZE
Titan Implants
Dental · 206d
Cleared Jul 05, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · LFX
Bayer Corp.
Microbiology · 121d
Cleared Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · HWC
Osteomed Corp.
Orthopedic · 97d
Cleared Jul 05, 2001
PREMIUM
K011130 · ELM
Heraeus Kulzer, Inc.
Dental · 83d
Cleared Jul 05, 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · HRS
Synthes (Usa)
Orthopedic · 79d
Cleared Jul 05, 2001
MOBILE-PATIENT VIEWER
K011436 · DPS
Data Critical Corporation
Cardiovascular · 56d
Cleared Jul 05, 2001
IN TEN-S
K011492 · EBF
Ivoclar North America, Inc.
Dental · 51d
Cleared Jul 05, 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · LZA
Kimberly-Clark Corp.
General Hospital · 31d
Cleared Jul 05, 2001
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
K011731 · JJY
Medical Analysis Systems, Inc.
Chemistry · 30d
Cleared Jul 05, 2001
POWDERED LATEX EXAMINATION GLOVES
K011922 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 15d
Cleared Jul 03, 2001
PRAIRIE CRUISER
K002580 · ITI
Raye'S, Inc.
Physical Medicine · 319d
Cleared Jul 03, 2001
BODYSTAT
K002835 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 294d
Cleared Jul 03, 2001
SMART RAD
K003438 · MQB
Cmt Medical Technologies, Ltd.
Radiology · 239d
Cleared Jul 03, 2001
HYALOMATRIX CO
K003855 · KHJ
Fidia Advanced Biopolymers Srl
Ear, Nose, Throat · 202d
Cleared Jul 03, 2001
SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE...
K011032 · LYC
Harvest Technologies, Corp.
Dental · 89d
Cleared Jul 03, 2001
WATERLASE, MILLENNIUM
K011041 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 89d
Cleared Jul 03, 2001
ETYMOTIC RESEARCH ER-10D OAE PROBE
K011114 · EWO
Etymotic Research
Ear, Nose, Throat · 82d
Cleared Jul 03, 2001
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
K011141 · JAK
Shimadzu Corp.
Radiology · 81d
Cleared Jul 03, 2001
STARBAND CRANIAL ORTHOSIS
K011350 · OAN
Orthomerica Products, Inc.
Neurology · 62d
Cleared Jul 03, 2001
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX,...
K011734 · DRF
Mogul Enterprises
Cardiovascular · 28d