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
98737–98760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1996
SAS SALMONELLA H Z15 ANTISERUM
K960610 · GRM
Sa Scientific, Inc.
Microbiology · 20d
Cleared Mar 04, 1996
LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE...
K960628 · HQY
Lanard Toys, Ltd.
Ophthalmic · 20d
Cleared Mar 01, 1996
HUMIDIFIER
K945782 · BTT
Respironics, Inc.
Anesthesiology · 462d
Cleared Mar 01, 1996
CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH
K950537 · DQC
Cardiophonics, Inc.
Cardiovascular · 388d
Cleared Mar 01, 1996
NARKOMED AV2+ ANESTHESIA VENTILATOR
K953228 · CBK
Draeger Medical, Inc.
Anesthesiology · 235d
Cleared Mar 01, 1996
DIAGNOSTIC ULTRASOUND TRANSDUCER
K953759 · ITX
Biosound, Inc.
Radiology · 203d
Cleared Mar 01, 1996
DIAGNOSTIC ULTRASOUND TRANDUCER
K953819 · ITX
Biosound, Inc.
Radiology · 199d
Cleared Mar 01, 1996
ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS
K954527 · KPO
Rockwell Medical Supply
Gastroenterology & Urology · 154d
Cleared Mar 01, 1996
PRIMUS VARIANT SYSTEM PVS99
K955283 · GKA
Primus Corp.
Hematology · 106d
Cleared Mar 01, 1996
RNA MEDICAL HEMAT CONTROL
K955630 · JJR
Bionostics, Inc.
Hematology · 81d
Cleared Mar 01, 1996
ALARA IMAGING SYSTEM
K955643 · EGY
Denoptix, Inc.
Radiology · 80d
Cleared Mar 01, 1996
COMPUMED DICON CLIENT
K955708 · LMD
Compumed, Inc.
Radiology · 78d
Cleared Mar 01, 1996
VALLEY FORGE BIPLOAR LOOP
K955764 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 72d
Cleared Mar 01, 1996
FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201
K955862 · GEX
Full Spectrum, Inc.
General & Plastic Surgery · 65d
Cleared Mar 01, 1996
BELTONE COMPOSER 2000 BTE HP
K955930 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 71d
Cleared Mar 01, 1996
ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM
K960028 · EAP
Dentsply Intl.
Radiology · 59d
Cleared Mar 01, 1996
ELECTROENCEPHALOGRAPH (EEG)
K960170 · GWF
Moberg Medical, Inc.
Neurology · 45d
Cleared Mar 01, 1996
POS-T-VAC AVP-1000 & MVP-700
K960342 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 37d
Cleared Mar 01, 1996
SURESKIN BORDER
K960393 · MGP
Euromed A/S
General & Plastic Surgery · 32d
Cleared Mar 01, 1996
SURESKIN STANDARD
K960394 · MGP
Euromed A/S
General & Plastic Surgery · 32d
Cleared Mar 01, 1996
SURESKIN THIN
K960404 · MGP
Euromed A/S
General & Plastic Surgery · 32d
Cleared Mar 01, 1996
EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
K960494 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 31d
Cleared Feb 29, 1996
SHARPSPRO-TECTOR
K942073 · FMI
Superior Diapering Products , Ltd.
General Hospital · 671d
Cleared Feb 29, 1996
CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
K950018 · DPS
Cambridge Heart, Inc.
Cardiovascular · 422d