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
79945–79968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2001
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
K011151 · FDS
The Olympus Optical Co.
Gastroenterology & Urology · 29d
Cleared May 15, 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
K011161 · LCM
Syva Co., Dade Behring, Inc.
Toxicology · 29d
Cleared May 15, 2001
BREEZY WHEELCHAIR, MODEL 300
K011268 · IOR
Sunrise Medical, Inc.
Physical Medicine · 19d
Cleared May 15, 2001
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
K011289 · DJG
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared May 15, 2001
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
K011314 · ITX
Aloka Co., Ltd.
Radiology · 15d
Cleared May 15, 2001
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
K011315 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared May 14, 2001
SMARTFLOW, MODEL SFIP 2000
K003122 · DSK
Florence Medical , Ltd.
Cardiovascular · 221d
Cleared May 14, 2001
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
K004012 · DYF
Impra, Inc.
Cardiovascular · 138d
Cleared May 14, 2001
EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
K010197 · FPA
Exelint International, Co.
General Hospital · 112d
Cleared May 14, 2001
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001
K010436 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 90d
Cleared May 14, 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457 · MBI
Arthrex, Inc.
Orthopedic · 87d
Cleared May 14, 2001
LIFELINES TRACKIT
K010460 · OLV
Lifelines , Ltd.
Neurology · 87d
Cleared May 14, 2001
DENSTAT
K010465 · GEI
Elmed, Inc.
General & Plastic Surgery · 87d
Cleared May 14, 2001
MAGNUM FLOW IRRIGATION SYSTEM
K010519 · GCJ
Scion Valley, Inc.
General & Plastic Surgery · 81d
Cleared May 14, 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · GAT
Arthrex, Inc.
General & Plastic Surgery · 69d
Cleared May 14, 2001
MODIFICATION TO SOLO
K011107 · INI
Ranger All Season Corp.
Physical Medicine · 28d
Cleared May 14, 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236 · FZP
Applied Medical Resources Corp.
General & Plastic Surgery · 21d
Cleared May 14, 2001
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K011380 · JEY
Bioplate, Inc.
Dental · 7d
Cleared May 11, 2001
BIOKNOTLESS ANCHOR
K002639 · GAM
Mitek Products
General & Plastic Surgery · 260d
Cleared May 11, 2001
CARDIAC FUNCTION LABORATORY
K003020 · DQO
Cd Leycom BV
Cardiovascular · 226d
Cleared May 11, 2001
BIOFIND
K003480 · GZO
Bio-Scan, Inc.
Neurology · 183d
Cleared May 11, 2001
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K003504 · KRO
Plus Orthopedics
Orthopedic · 179d
Cleared May 11, 2001
SKINGARD POLYCOAT GLOVE
K004018 · LYY
Top Quality Mfg., Inc.
General Hospital · 135d
Cleared May 11, 2001
E-POWER
K010395 · ITI
Dalton Medical Corp.
Physical Medicine · 91d