FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79321–79344 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · JAK
E-Z-Em, Inc.
Radiology · 30d
Cleared May 16, 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · MNH
Depuyacromed
Orthopedic · 28d
Cleared May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · JGS
Beckman Coulter, Inc.
Chemistry · 26d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH...
K011217 · DQO
Abbott Laboratories
Cardiovascular · 26d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared May 16, 2001
POWDER-FREE NITRILE EXAM GLOVE, BLUE
K011286 · LZA
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 19d
Cleared May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306 · JXM
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared May 15, 2001
GUIDANT RETRIEVER DEVICE
K001694 · DQY
Guidant Cardiac and Vascular Surgery
Cardiovascular · 347d
Cleared May 15, 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · GJS
Lifescan, Inc.
Hematology · 347d
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