Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145561–145584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1986
MEDILOG 2500 SYSTEM
K860078 · DSI
Oxford Medilog, Inc.
Cardiovascular · 49d
Cleared Feb 26, 1986
MEDILOG 4500 SYSTEM
K860079 · DSI
Oxford Medilog, Inc.
Cardiovascular · 49d
Cleared Feb 26, 1986
OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
K860106 · CCE
American Bentley
Anesthesiology · 44d
Cleared Feb 26, 1986
MODEL MR-30 HOLTER RECORDER
K860181 · DSH
Oxford Medilog, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1986
MODEL MR-35 HOLTER RECORDER
K860182 · DSH
Oxford Medilog, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1986
AFT-HEP SYSTEM
K860183 · DHN
Behring Diagnostics, Inc.
Immunology · 36d
Cleared Feb 26, 1986
MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE
K860449 · FIE
Top Corp.
Gastroenterology & Urology · 22d
Cleared Feb 26, 1986
UNITY DISPOSABLE INCONTINENT BRIEF
K860459 · EYQ
Bevan Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 25, 1986
PK-AC POWERED PATIENT MANUPULATING DEVICE
K854058 · FNG
Mannesmann Demag Corp.
General Hospital · 145d
Cleared Feb 25, 1986
FIBRELIGHT ILLUMINATING ORAL RETRACTORS
K854711 · EIG
Downs Surgical , Ltd.
Dental · 95d
Cleared Feb 25, 1986
RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER
K854806 · FPA
Grant Medical Center
General Hospital · 85d
Cleared Feb 25, 1986
SINGLE AND DUAL TOURNIQUET CUFF
K860463 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 19d
Cleared Feb 24, 1986
VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES
K853101 · DSY
Cobe Laboratories, Inc.
Cardiovascular · 216d
Cleared Feb 24, 1986
CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK
K853400 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 199d
Cleared Feb 24, 1986
CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA
K853471 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 189d
Cleared Feb 24, 1986
SONOLAYER SAL-55A/55AS
K853739 · IYO
Toshiba Medical Systems
Radiology · 171d
Cleared Feb 24, 1986
THE ANSWER HEARING AID
K854438 · ESD
Electone, Inc.
Ear, Nose, Throat · 111d
Cleared Feb 24, 1986
AMBI-24 PH/PRESSURE MONITOR
K854514 · FFT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 104d
Cleared Feb 24, 1986
ERMA PC-604 BLOOD CELL COUNTER
K854677 · GKL
Future Impex Corp.
Hematology · 96d
Cleared Feb 24, 1986
ERMA PC-602 PC-603 BLOOD CELL COUNTER
K854678 · GKL
Future Impex Corp.
Hematology · 81d
Cleared Feb 24, 1986
LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)
K854719 · LIO
Xsirius Scientific, Inc.
Microbiology · 94d
Cleared Feb 24, 1986
MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
K854726 · EXB
Pfizer, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 24, 1986
TRAVONEB MODEL # TONE 1
K854747 · BTI
Travomed, Inc.
Anesthesiology · 90d
Cleared Feb 24, 1986
LDS PEEP VALVE
K854822 · BYE
Life Design Systems, Inc.
Anesthesiology · 83d