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
152785–152808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1984
RABBIT KIDNEY CELLS
K841666 · KIR
Viromed Laboratories, Inc.
Pathology · 14d
Cleared May 07, 1984
MAC LEE SITZ BATH
K841711 · KTC
Mac Lee Medical Products
Physical Medicine · 13d
Cleared May 07, 1984
COLUMBIA CNA AGAR
K841754 · JSJ
The Montana Deaconess Medical Center
Microbiology · 10d
Cleared May 02, 1984
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089 · GQH
Clinical Sciences, Inc.
Microbiology · 233d
Cleared May 02, 1984
COMFEEL PROTECTIVE FILM
K833567 · EXB
Coloplast A/S
Gastroenterology & Urology · 203d
Cleared May 02, 1984
PERFORATOR BUR
K834093
Treace Medical, Inc.
General & Plastic Surgery · 156d
Cleared May 02, 1984
HSV ANTIGEN ELISA KIT
K834449 · LGC
Ortho Diagnostic Systems, Inc.
Microbiology · 135d
Cleared May 02, 1984
CELLTRAK-B
K834585 · FRZ
R&D Systems, Inc.
Hematology · 125d
Cleared May 02, 1984
RENAPAK CONCENTRATE MIXING SYS.
K840182 · FKQ
Renal Systems, Inc.
Gastroenterology & Urology · 106d
Cleared May 02, 1984
ACTIVE LIFE ONE-PIECE STOMA CAP
K840567 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 84d
Cleared May 02, 1984
ACTIVE LIFE ONE-PIECE CLOSED-END POUCH
K840568 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 84d
Cleared May 02, 1984
DIALYSIS ADMIN. SET - I.V.
K840654 · KOC
Cp Medical
Gastroenterology & Urology · 77d
Cleared May 02, 1984
PACEMAKER 147 VVI-THE OPTINIA
K840701 · DXY
Telectronics, Inc.
Cardiovascular · 75d
Cleared May 02, 1984
ENTEROCYSIS TUBE W/GUIDE WIRE & CONNECT
K840752 · KNT
E-Z-Em, Inc.
Gastroenterology & Urology · 69d
Cleared May 02, 1984
PEDIA-TRAKE CRICOTHYROTOMY KIT
K840925 · BTO
Intl. Medical Devices , Ltd.
Anesthesiology · 61d
Cleared May 02, 1984
FIBRINOGEN ASSAY KIT
K841020 · KQJ
Helena Laboratories
Hematology · 51d
Cleared May 02, 1984
TECHNICON RA-1000 SYS CO2
K841080 · CHS
Technicon Instruments Corp.
Chemistry · 50d
Cleared May 02, 1984
IMMPULSE AMIKACIN ASSAY REAGENTS
K841161 · KLQ
Paragon Diagnostics, Inc.
Toxicology · 44d
Cleared May 02, 1984
IMMPULSE GENTAMICIN ASSAY REAGENTS
K841162 · LCQ
Paragon Diagnostics, Inc.
Toxicology · 44d
Cleared May 02, 1984
URO-MALE INCONTINENCE CATHETER
K841224 · KNX
Gil-Med Industries C/O Kegan & Kegan,...
Gastroenterology & Urology · 41d
Cleared May 02, 1984
ASSIGNED VALUE FOR MEAN PLATELET
K841239 · JPK
Coulter Electronics, Inc.
Hematology · 40d
Cleared May 02, 1984
SPC DISPOSABLE CUTTER
K841247 · FZT
Surgical Products Corp.
General & Plastic Surgery · 42d
Cleared May 02, 1984
STA-POTENT SYSTEM
K841257 · LKY
Nu-Potent
Gastroenterology & Urology · 37d
Cleared May 02, 1984
ELVI 18
K841288 · JJN
Logos Scientific, Inc.
Chemistry · 35d