FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
78817–78840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2001
DYNATRON STS
K010565 · LIH
Dynatronics Corp.
Neurology · 78d
Cleared May 15, 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · FRN
Baxter Healthcare Corp
General Hospital · 78d
Cleared May 15, 2001
RANDOX IGE
K010855 · DGC
Randox Laboratories, Ltd.
Immunology · 54d
Cleared May 15, 2001
POWER TILT AND RECLINE SYSTEM
K010917 · ITI
Sunrise Medical, Inc.
Physical Medicine · 49d
Cleared May 15, 2001
DYNATRON STS RX
K010948 · LIH
Dynatronics Corp.
Neurology · 47d
Cleared May 15, 2001
TAPER-LOCK DENTAL IMPLANT SYSTEM
K011038 · DZE
Sulzer Dental, Inc.
Dental · 40d
Cleared May 15, 2001
DISPOSABLE BENDING CANNULA PR-233Q
K011149 · ODD
The Olympus Optical Co.
Gastroenterology & Urology · 29d
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