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
99865–99888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1995
OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM
K953961 · FWW
Osteonics Corp.
General Hospital · 99d
Cleared Nov 29, 1995
STC DIAGNOSTICS LSD MICRO-PLATE EIA
K954073 · DLB
Solarcare Technologies Corp,Inc.
Toxicology · 91d
Cleared Nov 29, 1995
CANYONS BI-DIRECTIONAL CHECK VALVE
K954181 · KYX
Canyon Medical Products
General Hospital · 84d
Cleared Nov 29, 1995
TECNOL SALINE WET DRESSING
K954243 · FRO
Tecnol Medical Products, Inc.
General & Plastic Surgery · 79d
Cleared Nov 29, 1995
ACI SINGLE LUMEN BIOPSY NEEDLE
K954264 · BTA
Advanced Cytometrix, Inc.
General & Plastic Surgery · 78d
Cleared Nov 29, 1995
ACI PULSATING VACUUM PUMP SYSTEM
K954286 · BTA
Advanced Cytometrix, Inc.
General & Plastic Surgery · 76d
Cleared Nov 29, 1995
ACI FINE NEEDLE ASPIRATION BIOPSY KIT
K954287 · BTA
Advanced Cytometrix, Inc.
General & Plastic Surgery · 76d
Cleared Nov 29, 1995
WHEEL LEMASTER
K954370 · IOR
Heliarc Specialists, Inc.
Physical Medicine · 72d
Cleared Nov 29, 1995
PROLASTIC SHEETING
K954382 · MIB
Pillar Surgical
General & Plastic Surgery · 71d
Cleared Nov 29, 1995
KELOCOTE
K954413 · MDA
Allied Biomedical Corp.
General & Plastic Surgery · 69d
Cleared Nov 29, 1995
BLADE, SCALPEL & BLADE, HANDEL
K954536 · OCZ
Access Surgical Intl., Inc.
Gastroenterology & Urology · 61d
Cleared Nov 29, 1995
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
K954726 · GCX
Stryker Endoscopy
General Hospital · 118d
Cleared Nov 29, 1995
COAT-A-COUNT DIRECT ANDROSTENEDIONE
K954755 · CIZ
Diagnostic Products Corp.
Chemistry · 44d
Cleared Nov 29, 1995
MYERSON IR DENTURE BASE
K954810 · EBI
Austenal, Inc.
Dental · 41d
Cleared Nov 29, 1995
ICU EXTENSION KIT
K954813 · FPA
Icu Medical, Inc.
General Hospital · 41d
Cleared Nov 29, 1995
VIDAMED SERIES 7205 ELECTROSURGICAL GENERATOR
K955035 · GEI
Vidamed, Inc.
General & Plastic Surgery · 27d
Cleared Nov 28, 1995
ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
K952470 · GCD
R-Group Intl.
General & Plastic Surgery · 186d
Cleared Nov 28, 1995
GLADIATOR ANTISHOCK PANTS
K953763 · LHX
Jobst Institute, Inc.
Anesthesiology · 109d
Cleared Nov 28, 1995
DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY...
K954317 · DYB
Daig Corp.
Cardiovascular · 74d
Cleared Nov 28, 1995
VACUTAINER BRAND PST PLASMA SEPARATION TUBE
K954592 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 57d
Cleared Nov 28, 1995
LIQUICHEK ETHANOL/AMMONIA CONTROL
K955024 · JJY
Bio-Rad
Chemistry · 26d
Cleared Nov 27, 1995
NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM
K945944 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 357d
Cleared Nov 27, 1995
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION...
K951566 · DYG
Baxter Healthcare Corp
Cardiovascular · 237d
Cleared Nov 27, 1995
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746 · CJE
Medical Diagnostic Technologies, Inc.
Chemistry · 164d