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
137881–137904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1987
PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323
K873975 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 24d
Cleared Oct 23, 1987
ADR-22 AUTOMATIC DIALYZER REPROCESSOR
K874034 · LIF
Biodynamics Corp.
Gastroenterology & Urology · 18d
Cleared Oct 22, 1987
TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO.
K871529 · FLL
Western Medical Equipment Corp.
General Hospital · 185d
Cleared Oct 22, 1987
PROVIDER IV. MODEL 5000 INFUSION DEVICE
K871806 · FRN
Pancretec, Inc.
General Hospital · 167d
Cleared Oct 22, 1987
LOOK FLUID DISTRIBUTION SET
K872945 · FPA
Look, Inc.
General Hospital · 86d
Cleared Oct 22, 1987
RESUBMITTED MICRON TRANSFUSION FILTER
K873873 · CAK
Travenol Laboratories, S.A.
General Hospital · 52d
Cleared Oct 22, 1987
MODIFIED MODELS 1025M & 1026T PACING LEAD
K873931 · DTB
Pacesetter Systems
Cardiovascular · 38d
Cleared Oct 20, 1987
AERO-VENT AEROSOL UNIT
K865107 · IYT
Medi Nuclear Corp., Inc.
Radiology · 293d
Cleared Oct 20, 1987
ALBUMIN SCREEN TEST
K870516 · JIQ
Sclavo, Inc.
Chemistry · 258d
Cleared Oct 20, 1987
IMED(R) 980C VOLUMETRIC INFUSION PUMP
K870656 · FRN
Imed Corp.
General Hospital · 244d
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