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
141697–141720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1987
APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC
K864393 · MSJ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 71d
Cleared Jan 16, 1987
BECKMAN EPSILON(TM) FERRITIN TEST KIT
K864437 · DBF
Beckman Instruments, Inc.
Immunology · 65d
Cleared Jan 15, 1987
AML II TITANIUM ACETABULUM PROSTHESIS
K861979 · JDI
Depuy, Inc.
Orthopedic · 239d
Cleared Jan 15, 1987
PROFILE HIP ACETABULUM PROSTHESIS
K863184 · JDI
Depuy, Inc.
Orthopedic · 149d
Cleared Jan 15, 1987
VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
K863420 · CCJ
Vitalograph , Ltd.
Anesthesiology · 133d
Cleared Jan 15, 1987
CART, ORTHOPEDIC BED, STRYKER
K863685 · FNJ
Brenner Metal Prod Corp.
General Hospital · 118d
Cleared Jan 15, 1987
SPIROMETRICS MODEL 2500 FLOWMATE(TM)
K863953 · BZM
Spirometrics, Inc.
Anesthesiology · 97d
Cleared Jan 15, 1987
MA-2 AND MA2+2 VOLUME VENTILATORS
K864430
Puritan Bennett Corp.
Anesthesiology · 64d
Cleared Jan 15, 1987
ANESTHESIA RECORDER
K864806 · BSZ
Draeger Medical, Inc.
Anesthesiology · 37d
Cleared Jan 15, 1987
VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS
K864822 · BTC
Surgidyne, Inc.
Anesthesiology · 37d
Cleared Jan 15, 1987
SPIROVISION
K864885 · BZM
Futuremed Div. of Future Impex Corp.
Anesthesiology · 34d
Cleared Jan 15, 1987
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
K865046 · BZA
Salter Labs
Anesthesiology · 22d
Cleared Jan 15, 1987
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061 · BTO
Shiley, Inc.
Anesthesiology · 22d
Cleared Jan 15, 1987
SAFE-T-SHIELD MOUTHPIECE
K865093 · BYP
Medi Nuclear Corp., Inc.
Anesthesiology · 16d
Cleared Jan 14, 1987
THE IMAGE/R
K862294 · LLZ
Quantum Diagnostics, Ltd.
Radiology · 211d
Cleared Jan 14, 1987
PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT
K862483 · CDZ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 198d
Cleared Jan 14, 1987
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR
K863042 · DSK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 155d
Cleared Jan 14, 1987
DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE
K863132 · LLZ
General Electric Co.
Radiology · 152d
Cleared Jan 14, 1987
SYSTEM 90 TRANSPORT
K863219 · DSP
Datascope Corp.
Cardiovascular · 147d
Cleared Jan 14, 1987
CARDS(TM) - EARLY PREGNANCY TEST
K863341 · LCX
Pacific Biotech, Inc.
Chemistry · 139d
Cleared Jan 14, 1987
MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER
K863532 · FRN
Parker Hannifin Corp.
General Hospital · 127d
Cleared Jan 14, 1987
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
K863842 · KLT
Miles Laboratories, Inc.
Toxicology · 105d
Cleared Jan 14, 1987
E-Z HOLD - #4060
K864190 · KMK
John F. Greer Co., Inc.
General Hospital · 79d
Cleared Jan 14, 1987
PALMER OBSTETRIC BRACE
K864194 · KNC
Ad-Tech Medical Instrument Corp
Obstetrics & Gynecology · 79d