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
126793–126816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1990
GRANDCOR/CARDIOLINE ECT STRESS TESTING
K895547 · DSI
Grandcor Medical Systems
Cardiovascular · 181d
Cleared Mar 13, 1990
L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET
K895824 · FPD
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 165d
Cleared Mar 13, 1990
CURITY(R) PERCUTANEOUS CATHETERS
K895972 · DQY
Kendall Healthcare Products Co....
Cardiovascular · 152d
Cleared Mar 13, 1990
INFANT FEEDING TUBE
K896559 · FPD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 116d
Cleared Mar 13, 1990
L.T.C. REPLACEMENT GASTROSTOMY TUBE
K896621 · KCQ
Intl. Medical Marketing, Inc.
Dental · 112d
Cleared Mar 13, 1990
CORE BUILD UP COMPOSITE
K896950 · EBF
Confi-Dental Products Co.
Dental · 90d
Cleared Mar 13, 1990
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
K896958 · DXN
Medical Data Electronics
Cardiovascular · 89d
Cleared Mar 13, 1990
NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
K897004 · DXG
Advanced Technology Laboratories, Inc.
Cardiovascular · 85d
Cleared Mar 13, 1990
ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
K897115 · IZI
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Mar 13, 1990
ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM
K897126 · CAC
Atrium Medical Corp.
Anesthesiology · 77d
Cleared Mar 13, 1990
ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD
K897127 · CAC
Atrium Medical Corp.
Anesthesiology · 77d
Cleared Mar 13, 1990
DISPOSABLE CO2 ABSORBER/E
K897171 · CBL
Gibeck, Inc.
Anesthesiology · 75d
Cleared Mar 13, 1990
MODIFIED GORE-TEX SURGICAL TAPE
K900195 · MCA
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 61d
Cleared Mar 13, 1990
RAPID NF SYSTEM
K900517 · JSW
Innovative Diagnostic Systems, Inc.
Microbiology · 39d
Cleared Mar 13, 1990
CONSTANT CURRENT STIMULATOR MODEL 022101
K900553 · JOQ
Ep Technologies, Inc.
Cardiovascular · 35d
Cleared Mar 13, 1990
'CONDUCTOR' DISPOSABLE TENS ELECTRODE
K900606 · GXY
Medical Science Products, Inc.
Neurology · 33d
Cleared Mar 13, 1990
TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
K900660 · JAK
Philips Medical Systems North...
Radiology · 32d
Cleared Mar 13, 1990
REMOTE CONTROL SWITCH
K900969 · IQA
Baylor Biomedical Services
Physical Medicine · 11d
Cleared Mar 13, 1990
K-STERILE TENS ELECTRODES
K900997 · GXY
Katecho, Inc.
Neurology · 11d
Cleared Mar 13, 1990
ENVIRONMENTAL CONTROL UNIT MODEL 7000
K901028 · IQA
Baylor Biomedical Services
Physical Medicine · 7d
Cleared Mar 13, 1990
YES-NO VOICE BOX 7011
K901029 · ILQ
Baylor Biomedical Services
Physical Medicine · 7d
Cleared Mar 13, 1990
ROTARY COMMUNICATION SCANNER MODEL 7010
K901030 · ILQ
Baylor Biomedical Services
Physical Medicine · 7d
Cleared Mar 12, 1990
MODIFIED 225/SIMV VOLUME VENTILATOR
K884389 · CBK
Monaghan Medical Corp.
Anesthesiology · 510d
Cleared Mar 12, 1990
Q-PORT SYSTEM KIT
K894650 · LJT
Quinton, Inc.
General Hospital · 231d