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
133369–133392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1988
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217 · LKL
Technicon Instruments Corp.
Immunology · 23d
Cleared Nov 04, 1988
ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)
K884400 · DHN
Immco Diagnostics, Inc.
Immunology · 16d
Cleared Nov 03, 1988
SYMBION CENTRIFUGAL BLOOD PUMP MODEL I
K882129 · KFM
Symbion, Inc.
Cardiovascular · 167d
Cleared Nov 03, 1988
CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY
K882271 · LLZ
Nuccardiac Software, Inc.
Radiology · 156d
Cleared Nov 03, 1988
VARITEST
K882547 · JOM
Eureka AB
Cardiovascular · 135d
Cleared Nov 03, 1988
CAPD DISPOSABLE Y SYSTEM - DY SET
K883393 · KDJ
Medionics International , Ltd.
Gastroenterology & Urology · 86d
Cleared Nov 03, 1988
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 73d
Cleared Nov 03, 1988
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
K883603 · DWC
3M Health Care, Sarns
Cardiovascular · 72d
Cleared Nov 03, 1988
PREDICTOR II SIGNAL AVERAGING ECG
K883855 · DXG
Corazonix Corp.
Cardiovascular · 51d
Cleared Nov 03, 1988
GUIDING CATHETER (TIP SOFTNESS CHANGE)
K883981 · DWF
Devices For Vascular Intervention, Inc.
Cardiovascular · 43d
Cleared Nov 03, 1988
PREMIER DECANNULATION STOPPER
K884015 · BTO
Premier Dental
Anesthesiology · 42d
Cleared Nov 03, 1988
COHERENT EXCELITE CO2 AIR FIBER
K884204 · GEX
Coherent Medical Lasers
General & Plastic Surgery · 28d
Cleared Nov 03, 1988
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · LIO
Bio-Rad
Microbiology · 20d
Cleared Nov 02, 1988
ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE
K880639 · FLL
Human Technologies, Inc.
General Hospital · 260d
Cleared Nov 02, 1988
MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.
K882352 · CCL
Clinical Information Systems, Inc.
Anesthesiology · 148d
Cleared Nov 02, 1988
HEALTH-WATCH BED MONITOR
K882377 · BZQ
Engineering Developments, Co.
Anesthesiology · 147d
Cleared Nov 02, 1988
CO2 SURGICAL LASER SYSTEM MODEL #IR105
K882951 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 111d
Cleared Nov 02, 1988
CO2 SURGICAL LASER SYSTEM MODEL #IR106
K882952 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 111d
Cleared Nov 02, 1988
TS1000 SUCTION TIP
K883384 · BSY
M.D. Engineering, Inc.
Anesthesiology · 85d
Cleared Nov 02, 1988
OXYTROL
K883590 · NFB
Cryogenic Assoc.
Anesthesiology · 72d
Cleared Nov 02, 1988
MARK-5 CONCENTRATOR
K883591 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 71d
Cleared Nov 02, 1988
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119 · FLL
S & W Medico Teknik
General Hospital · 33d
Cleared Nov 02, 1988
SPQ(TM) TEST SYSTEM FOR PREALBUMIN
K884297 · JZJ
Atlantic Antibodies
Immunology · 21d
Cleared Nov 02, 1988
SPQ(TM) TEST SYSTEM FOR MICROALBUMIN
K884298 · JZJ
Atlantic Antibodies
Immunology · 21d