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
95305–95328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1996
SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM
K960771 · FPA
Rymed Technologies, Inc.
General Hospital · 288d
Cleared Dec 10, 1996
ESORT II + 400 SERIES MONITOR
K961138 · DRO
Medical Data Electronics
Cardiovascular · 264d
Cleared Dec 10, 1996
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
K961223 · LOS
Criticare Systems, Inc.
Cardiovascular · 256d
Cleared Dec 10, 1996
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
K961908 · JPA
Helena Laboratories
Hematology · 208d
Cleared Dec 10, 1996
PORPHOBILINOGEN (PBG)
K961984 · JNF
Trace America, Inc.
Chemistry · 203d
Cleared Dec 10, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
K962598 · CEW
Nichols Institute Diagnostics
Chemistry · 161d
Cleared Dec 10, 1996
VITAJET
K962625 · KZE
Vitajet Corp.
General Hospital · 158d
Cleared Dec 10, 1996
CEDIA DAU BENZODIAZEPINE ASSAY
K962734 · JXM
Boehringer Mannheim Corp.
Toxicology · 148d
Cleared Dec 10, 1996
ACTIS (VENOUS FLOW CONTROLLER)
K962915 · LKY
Vivus, Inc.
Gastroenterology & Urology · 137d
Cleared Dec 10, 1996
VERDICT PCP
K963692 · LCM
Editek, Inc.
Toxicology · 85d
Cleared Dec 10, 1996
DIGOXIN ENZYME IMMUNOASSAY
K963835 · KXT
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Dec 10, 1996
KSEA THERMOCOAGULATOR (MODEL 265100 20)
K963852 · HGI
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 76d
Cleared Dec 10, 1996
LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
K963924 · CAF
Pari Holding Co.
Anesthesiology · 71d
Cleared Dec 10, 1996
ARDENT FUTURA NON GAMMA-2
K964775 · EJJ
Ardent Production Development
Dental · 54d
Cleared Dec 09, 1996
TRANSFLOW TEST
K953990 · BZC
P.K. Morgan , Ltd.
Anesthesiology · 473d
Cleared Dec 09, 1996
MEDICOTEST ECG ELECTRODES
K961643 · DRX
Medicotest, Inc.
Cardiovascular · 224d
Cleared Dec 09, 1996
SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM
K961937 · DQD
Delphi Consulting Group
Cardiovascular · 203d
Cleared Dec 09, 1996
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314 · KWP
Osteonics Corp.
Orthopedic · 175d
Cleared Dec 09, 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · MNH
Synthes (Usa)
Orthopedic · 159d
Cleared Dec 09, 1996
ML MICROKERATOME BLADE
K962661 · HNO
Med-Logics, Inc.
Ophthalmic · 154d
Cleared Dec 09, 1996
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
K962880 · CAZ
Sherwood Medical Co.
Anesthesiology · 138d
Cleared Dec 09, 1996
DMS-1000C DERMOABRADER
K963204 · GFE
Aesthetic Lasers, Inc.
General & Plastic Surgery · 116d
Cleared Dec 09, 1996
KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
K963796 · JWH
Howmedica Corp.
Orthopedic · 77d
Cleared Dec 09, 1996
ULTIMA FX FEMORAL HIP STEMS
K963885 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 74d