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
144169–144192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1986
CRIB CUDDLE - INFANT BED
K845004 · FMS
International Purchasing Services
General Hospital · 483d
Cleared Apr 23, 1986
NO FLOSS FLOSSER
K854326 · JEQ
Rgm Assoc.
Dental · 177d
Cleared Apr 23, 1986
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
K854590 · JAF
Philips Medical Systems, Inc.
Radiology · 156d
Cleared Apr 23, 1986
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
K854591 · JAF
Philips Medical Systems, Inc.
Radiology · 156d
Cleared Apr 23, 1986
5000 SERIES ECG ELECTRODES
K854757 · DRX
Alternative Design Systems, Inc.
Cardiovascular · 147d
Cleared Apr 23, 1986
MODIFIED CHERNE CAD DETECTOR
K860015 · DXG
Cherne Industries, Inc.
Cardiovascular · 110d
Cleared Apr 23, 1986
TA-6C - PART NUMBER SLZ 7520
K860262 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 89d
Cleared Apr 23, 1986
MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY
K860273 · GEX
Britt Corp., Inc.
General & Plastic Surgery · 86d
Cleared Apr 23, 1986
URDYN 5000 (UROFLOWMETER)
K860368 · FFO
Dantec Electronics, Inc.
Gastroenterology & Urology · 79d
Cleared Apr 23, 1986
MEADOX SURGIMED GUIDE CATHETER
K860429 · DQO
Meadox Surgimed, Inc.
Cardiovascular · 78d
Cleared Apr 23, 1986
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
K860546 · KRG
Pacesetter Systems
Cardiovascular · 69d
Cleared Apr 23, 1986
MODEL E 600 ELECTROCARDIOGRAPH
K860767 · DSI
Kone Instruments, Inc.
Cardiovascular · 51d
Cleared Apr 23, 1986
VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE
K860771 · GCQ
Van-Tec, Inc.
Gastroenterology & Urology · 51d
Cleared Apr 23, 1986
GUIDED WIRE TORQUER
K860840 · DQX
Target Therapeutics
Cardiovascular · 50d
Cleared Apr 23, 1986
ANGIOJECT
K860842 · DXT
Target Therapeutics
Cardiovascular · 50d
Cleared Apr 23, 1986
CATHETER INTRODUCER
K860958 · DYB
Target Therapeutics
Cardiovascular · 41d
Cleared Apr 23, 1986
BIPOLAR CARDIAC PACEMAKER, MODEL 110
K861009 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 36d
Cleared Apr 23, 1986
LABOR-DELIVERY STRETCH/BED
K861030 · KNC
Adel Medical , Ltd.
Obstetrics & Gynecology · 36d
Cleared Apr 23, 1986
MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT
K861045 · LLO
Sharplan Industries, Inc.
Anesthesiology · 36d
Cleared Apr 23, 1986
MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER
K861110 · DTB
Intermedics, Inc.
Cardiovascular · 29d
Cleared Apr 23, 1986
ER-7C CLINICAL PROBE MICROPHONE
K861113 · ETW
Etymotic Research
Ear, Nose, Throat · 29d
Cleared Apr 23, 1986
DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
K861153 · FMF
Exel Intl.
General Hospital · 28d
Cleared Apr 23, 1986
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K861174 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 23, 1986
GENTLE BACK, PLASTIC URINARY DRAINAGE BAG
K861192 · KNX
Advanced Clinical Products, Inc.
Gastroenterology & Urology · 23d