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
76633–76656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · DSK
Radi Medical Systems AB
Cardiovascular · 19d
Cleared Dec 18, 2001
MODIFICATION TO ALPHA DX SYSTEM
K014024 · MMI
First Medical, Inc.
Chemistry · 12d
Cleared Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
K014034 · JFL
Beckman Coulter, Inc.
Chemistry · 11d
Cleared Dec 18, 2001
CRESCO TI IMPLANT CONCEPT
K981052 · DZE
Cresco TI Systems AB
Dental · 1366d
Cleared Dec 17, 2001
POLESTAR N-10
K010850 · LNH
Odin Medical Technologies , Ltd.
Radiology · 271d
Cleared Dec 17, 2001
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
K011323 · NHG
Salimetrics, LLC
Chemistry · 230d
Cleared Dec 17, 2001
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE...
K013302 · KGO
Allegiance Healthcare Corp.
General Hospital · 75d
Cleared Dec 17, 2001
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K013317 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 74d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Dec 17, 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 62d
Cleared Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
K013534 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 55d
Cleared Dec 17, 2001
OSSEOTITE DENTAL IMPLANTS
K013570 · DZE
Implant Innovations, Inc.
Dental · 52d
Cleared Dec 17, 2001
DRG ORTHOHEX SS BONE SCREW
K013786 · HWC
Doctor'S Research Group, Inc.
Orthopedic · 33d
Cleared Dec 17, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
K013903 · HWC
Triad Medical, Inc.
Orthopedic · 21d
Cleared Dec 17, 2001
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
K013972 · LKF
Ackard Laboratories
Obstetrics & Gynecology · 14d
Cleared Dec 14, 2001
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
K011197 · FTC
Lumenis
General & Plastic Surgery · 239d
Cleared Dec 14, 2001
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · MMI
Tosoh Medics, Inc.
Chemistry · 113d
Cleared Dec 14, 2001
ORTHOSONIX ENERGEX
K013094 · NHH
Orthosonix, Inc.
Neurology · 88d
Cleared Dec 14, 2001
ASMOTOM AUTOMATED TREPHINE SYSTEM
K013151 · HRG
Bkg Opthalmics USA, Inc.
Ophthalmic · 85d
Cleared Dec 14, 2001
RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
K013200 · CAH
Rennels Medical Corp.
General Hospital · 80d
Cleared Dec 14, 2001
GORE INTRODUCER SHEATH
K013282 · DBY
W.L. Gore & Associates, Inc.
Immunology · 73d
Cleared Dec 14, 2001
NIPRO HYPODERMIC NEEDLE
K013293 · FMI
Nipro Medical Corp.
General Hospital · 73d
Cleared Dec 14, 2001
CTS-415
K013327 · IYO
Shantou Institute of Ultrasonic...
Radiology · 70d
Cleared Dec 14, 2001
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
K013401 · MQG
K-Systems, Kivex Biotec , Ltd.
Obstetrics & Gynecology · 60d