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
78505–78528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2001
SELF-ADHESIVE ELECTRODES
K011411 · GXY
Pain Management Technologies
Neurology · 36d
Cleared Jun 13, 2001
SILICONE IMPRESSION MATERIAL
K011450 · ELW
Northeast Resins & Silicones, LLC
Dental · 33d
Cleared Jun 13, 2001
OIL FOR TISSUE CULTURE
K011462 · MQL
Conception Technologies
Obstetrics & Gynecology · 30d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
K011463 · JJX
Ortho-Clinical Diagnostics
Chemistry · 30d
Cleared Jun 13, 2001
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL...
K011464 · DQY
Vascular Intervention
Cardiovascular · 30d
Cleared Jun 13, 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · HRY
Biomet, Inc.
Orthopedic · 28d
Cleared Jun 13, 2001
FAST THERMOMETER MODELS ST713C AND ST713F
K011585 · FLL
Mesure Technology
General Hospital · 21d
Cleared Jun 13, 2001
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
K011598 · MTW
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 20d
Cleared Jun 13, 2001
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
K011693 · FSY
Trumpf Medical Systems, Inc.
General & Plastic Surgery · 13d
Cleared Jun 13, 2001
WORLAND UNICONDYLAR TIBIAL BEARING
K011795 · HRY
Biomet, Inc.
Orthopedic · 5d
Cleared Jun 12, 2001
GERATHERM BABYWATCH TEMPERATURE MONITOR
K001281 · FLL
Geratherm AG
General Hospital · 417d
Cleared Jun 12, 2001
MULTI-STIM, MODEL MS-100
K001897 · GZJ
Metron Medical Australia, Pty, Ltd.
Neurology · 356d
Cleared Jun 12, 2001
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 256d
Cleared Jun 12, 2001
MEDCOMP ULTRA-FLOW CATHETER
K003207 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 242d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
Cleared Jun 12, 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · GZJ
Biomedical Life Systems, Inc.
Neurology · 140d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · KTT
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 12, 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K010770 · MWI
Bci, Inc.
Cardiovascular · 90d
Cleared Jun 12, 2001
BIOCELLECT
K010775 · LYC
Imtec Corp.
Dental · 90d
Cleared Jun 12, 2001
TROCHANTERIC NAIL
K010780 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jun 12, 2001
HEARTCARD, MODEL 5258
K010945 · DXH
Instromedix
Cardiovascular · 75d
Cleared Jun 12, 2001
ISOLA BAND CLAMP
K010972 · MNI
Depuyacromed
Orthopedic · 71d
Cleared Jun 12, 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · MBI
Arthrex, Inc.
Orthopedic · 69d
Cleared Jun 12, 2001
NAC PLUS NEEDLELESS ACCESS CONNECTOR
K011193 · FPA
Porex Medical Products
General Hospital · 54d