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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
129961–129984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1989
LATEX EXAMINATION GLOVES
K894195 · LYY
Jiahn Chiaur Enterprise Co., Ltd.
General Hospital · 44d
Cleared Jul 28, 1989
QUIDEL FOOD ALLERGEN SCREEN
K894253 · DHB
Quidel Corp.
Immunology · 38d
Cleared Jul 28, 1989
ELECTRO-LITE POWER WHEELCHAIR
K894344 · ITI
Damaco
Physical Medicine · 14d
Cleared Jul 27, 1989
ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER
K884271 · IYO
Acuson Corp.
Radiology · 289d
Cleared Jul 27, 1989
TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
K884972 · GZJ
Futuremed Div. of Future Impex Corp.
Neurology · 239d
Cleared Jul 27, 1989
IMEX RHYTHM TEK
K890114 · DSH
Racom, Inc.
Cardiovascular · 197d
Cleared Jul 27, 1989
SYRINGE INFUSION PUMP
K890120 · FRN
Medfusion, Inc.
General Hospital · 197d
Cleared Jul 27, 1989
PERMAGUM PUTTY SOFT & PERMAGUM GARRANT
K890449 · ELW
Wacker-Chemie GmbH
Dental · 181d
Cleared Jul 27, 1989
AD-TECH'S DEPTH ELECTRODE
K891920 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 122d
Cleared Jul 27, 1989
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES
K892930 · CKA
Technicon Instruments Corp.
Chemistry · 97d
Cleared Jul 27, 1989
PACER R 9 TREADMILL
K893032 · IOL
Pacer Industries, Inc.
Physical Medicine · 94d
Cleared Jul 27, 1989
KIT, INTRAVENOUS EXTENSION TUBING
K893120 · FPA
Island Medical
General Hospital · 93d
Cleared Jul 27, 1989
MULTI-GAS ANALYZER (MGA)
K893589 · CCK
Marquette Gas Analysis Corp.
Anesthesiology · 79d
Cleared Jul 27, 1989
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY
K893684 · CGN
Ciba Corning Diagnostics Corp.
Chemistry · 72d
Cleared Jul 27, 1989
CHARISE CHARLES REAGENT BLOOD STRIPS
K893894 · JIO
Lee Import Domestic Consulting
Hematology · 58d
Cleared Jul 27, 1989
ELECTRA 1000C AUTOMATIC COAGULATION TIMER
K894052 · GKP
Medical Laboratory Automation...
Hematology · 50d
Cleared Jul 27, 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · DXH
Medtronic Vascular
Cardiovascular · 44d
Cleared Jul 27, 1989
ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR
K894345 · IOR
Damaco
Physical Medicine · 13d
Cleared Jul 27, 1989
OPMILAS CO2-L
K894393 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 10d
Cleared Jul 25, 1989
PHYNE-VU
K885096 · FRO
Medical Resources, Ltd.
General & Plastic Surgery · 228d
Cleared Jul 25, 1989
LYME DISEASE MICROASSAY
K890843 · LSR
Diamedix Corp.
Microbiology · 154d
Cleared Jul 25, 1989
SIEMENS CEILING STAND 800F, 800 AND 810
K891023 · LDQ
Siemens Medical Electronics
General & Plastic Surgery · 147d
Cleared Jul 25, 1989
BODY COOLER OR COOLVEST OR ALPHA BODY COOLER
K891603 · ILO
Alpha Rehabilitation Products
Physical Medicine · 127d
Cleared Jul 25, 1989
GENETIC SYSTEMS MICROPLATE READER
K891767 · JJQ
Genetic Systems Corp.
Chemistry · 123d