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

Filters: Cleared only ×
175,820 results
138481–138504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1987
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726 · JOP
General Electric Co.
Cardiovascular · 238d
Cleared Oct 20, 1987
CONDOM TAKASO RUBBER PRODUCTS SDN/BDH
K871036 · HIS
Takaso Rubber C/O Interstate...
Obstetrics & Gynecology · 217d
Cleared Oct 20, 1987
PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR
K871344 · DSI
Reynolds Medical , Ltd.
Cardiovascular · 197d
Cleared Oct 20, 1987
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
K871446 · KGI
Hologic, Inc.
Radiology · 190d
Cleared Oct 20, 1987
GENERAL PURPOSE COMBINATION PH ELECTRODE
K871921 · FFT
Chemfet Corp.
Gastroenterology & Urology · 155d
Cleared Oct 20, 1987
PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA.
K871922 · FFT
Chemfet Corp.
Gastroenterology & Urology · 155d
Cleared Oct 20, 1987
ANGEL LATEX PROPHYLACTICS (CONDOMS)
K871948 · HIS
Angel Intl. Trading Co., Inc.
Obstetrics & Gynecology · 153d
Cleared Oct 20, 1987
CHROMOTITRE E.I.A. TOXOPLASMA IGM
K872070 · LGD
Ismunit Istituto Immunologico Intaliano
Microbiology · 144d
Cleared Oct 20, 1987
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
K872505 · CGA
Home Diagnostics, Inc.
Chemistry · 118d
Cleared Oct 20, 1987
EUROGENETICS CRP ELISA
K872539 · DCN
Eurogenetics
Immunology · 113d
Cleared Oct 20, 1987
RESULT PLUS/HCG PREGNANCY TEST
K872730 · JHI
Ortho Diagnostic Systems, Inc.
Chemistry · 104d
Cleared Oct 20, 1987
PROPHYLACTIC (CONDOM)
K872736 · HIS
Circle Rubber Corp.
Obstetrics & Gynecology · 103d
Cleared Oct 20, 1987
NUTRIPUMP
K872741 · FRN
I M, Inc.
General Hospital · 102d
Cleared Oct 20, 1987
WARM WEIGH MODELS I-20/W-30 INFANT SCALE
K872742 · FMT
Air-Shields, Inc.
General Hospital · 102d
Cleared Oct 20, 1987
POREX NERVE LOCATOR
K872791 · ETN
Porex Medical
Ear, Nose, Throat · 98d
Cleared Oct 20, 1987
ANTINUCLEAR ANTIBODY TEST
K872839 · LJM
Cappel Diagnostics, Inc.
Immunology · 92d
Cleared Oct 20, 1987
ENDOMETRIAL SAMPLER
K872908 · HHK
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 20, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K872946 · DHB
Pharmacia, Inc.
Immunology · 84d
Cleared Oct 20, 1987
ULTRASONIC AIR-IN-LINE DETECTOR (AILD)
K872952 · FRN
Imed Corp.
General Hospital · 84d
Cleared Oct 20, 1987
BREAST-SCAN(TM)
K872962 · LHM
Thermascan, Inc.
Radiology · 83d
Cleared Oct 20, 1987
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Oct 20, 1987
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · FOZ
C.R. Bard, Inc.
General Hospital · 77d
Cleared Oct 20, 1987
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · CGJ
American Dade
Chemistry · 77d
Cleared Oct 20, 1987
OXYGEN ANALYZER MODEL 800 SERIES
K873068 · CCL
Salter Instrumentation, Inc.
Anesthesiology · 75d