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
80041–80064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2001
DUO-DENT DENTAL IMPLANT
K010386 · DZE
Duo-Dent Dental Implant Systems, LLC
Dental · 19d
Cleared Feb 27, 2001
MODEL THERMO TEK QUICKCARE
K010502 · FLL
Saat , Ltd.
General Hospital · 6d
Cleared Feb 23, 2001
MAEDA NEW NEEDLE DISPOSABLE
K000581 · MQX
Maeda Toyokichi Shoten
General Hospital · 367d
Cleared Feb 23, 2001
EASE-A-CULT
K002756 · KHE
Diagnostica, Inc.
Hematology · 171d
Cleared Feb 23, 2001
ORTHOPILOT
K003347 · HAW
Kinamed, Inc.
Neurology · 121d
Cleared Feb 23, 2001
FREEDLAND TENSION SYSTEM
K003648 · MBI
Etzem Technologies, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
TRITON HIP SYSTEM
K003649 · LWJ
Hayes Medical, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
FADASSI MEDICAL FM-1 NO BLENDER
K003665 · MRO
Fadasis Medical, Inc.
Anesthesiology · 87d
Cleared Feb 23, 2001
PERCUSSIVENEB, MODEL PN-2001
K003684 · NHJ
Vortran Medical Technology 1, Inc.
Anesthesiology · 86d
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