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
79537–79560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2001
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
K003749 · FYC
Banta Healthcare
General Hospital · 81d
Cleared Feb 23, 2001
MICROTARGETING DRIVE SYSTEM
K003776 · HAW
FHC, Inc.
Neurology · 78d
Cleared Feb 23, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003834 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Feb 23, 2001
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
K010021 · FOZ
Medical Components, Inc.
General Hospital · 51d
Cleared Feb 23, 2001
ENA SCREEN EIA KIT
K010148 · LLL
The Binding Site, Ltd.
Immunology · 37d
Cleared Feb 23, 2001
STERILE POWDERED LATEX SURGEON GLOVES
K010198 · KGO
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 32d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 22, 2001
CORTEX METAMAX
K001631 · BZC
Cortex Biophysik GmbH
Anesthesiology · 272d
Cleared Feb 22, 2001
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K002079 · MKJ
Medicotest A/S
Cardiovascular · 227d
Cleared Feb 22, 2001
MEDLOGICS ML 4000, MODEL 4000
K002515 · HNO
Med-Logics, Inc.
Ophthalmic · 191d
Cleared Feb 22, 2001
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT...
K002758 · DSI
Agilent Technologies Deutschland GmbH
Cardiovascular · 170d
Cleared Feb 22, 2001
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
K003260 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 127d
Cleared Feb 22, 2001
Z-TOUCH
K003268 · HAW
Brainlab AG
Neurology · 127d
Cleared Feb 22, 2001
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
K003423 · FTD
St. Francis Medical Equipment Co., Ltd.
General & Plastic Surgery · 111d
Cleared Feb 22, 2001
MTP RESESURFACING JOINT-SMALL/9301-01
K003629 · KWD
Terray Corp.
Orthopedic · 90d
Cleared Feb 22, 2001
MINIENDO III
K003640 · ELB
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Feb 22, 2001
SUTUREGROOVE WEIGHT SIZING SET
K003646 · MML
Iop, Inc.
Ophthalmic · 87d
Cleared Feb 22, 2001
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
K003672 · IYO
Medge Platforms, Inc.
Radiology · 86d
Cleared Feb 22, 2001
TAUT-INSUFFLATION NEEDLE
K003703 · HIF
Taut, Inc.
Obstetrics & Gynecology · 83d
Cleared Feb 22, 2001
URETEROSCOPES
K003806 · FGB
Global Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 22, 2001
CYSTOSCOPES
K003807 · FAJ
Global Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 22, 2001
VISULAS YAG II
K003885 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 69d
Cleared Feb 22, 2001
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
K003914 · GWG
Medtronic PS Medical
Neurology · 65d
Cleared Feb 22, 2001
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
K010007 · GCJ
Taut, Inc.
General & Plastic Surgery · 51d