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
137329–137352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1987
CONVERTA-LITTER
K874060 · INN
Camtec
Physical Medicine · 66d
Cleared Dec 10, 1987
POWER EXERCISE EQUIPMENT
K874196 · BXB
Arc Motion , Ltd.
Physical Medicine · 57d
Cleared Dec 10, 1987
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · LIQ
Abbott Laboratories
Microbiology · 45d
Cleared Dec 10, 1987
THOMPSON HIP PROSTHESIS
K874617 · JDG
Orthopedic Systems, Inc.
Orthopedic · 31d
Cleared Dec 10, 1987
STERI-CLENS(TM) SURGICAL SCRUB SPONGE
K874741 · GEC
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 17d
Cleared Dec 10, 1987
OTICON MODEL I50 IN-THE-EAR HEARING AID
K874744 · ESD
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Dec 10, 1987
CK 4900 SERIES, GOWN AND TOWEL PAK
K874760 · LRO
Currie Medical Specialties, Inc.
General & Plastic Surgery · 21d
Cleared Dec 10, 1987
ARTHROTRACT UPPER LIMB TRACTION ACCESSORY
K874762 · JEA
Andronic Devices, Ltd.
General & Plastic Surgery · 21d
Cleared Dec 10, 1987
HEARING AID (ALL-IN-THE-EAR) MODEL WORD SORTER
K874764 · ESD
Clear Corp.
Ear, Nose, Throat · 21d
Cleared Dec 10, 1987
INTERPRO INT'L, INC. ISOLATION GOWN
K874766 · FYC
Interpro Intl., Inc.
General Hospital · 21d
Cleared Dec 09, 1987
MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.
K873887 · KDI
W.R. Grace & Co.-Conn.
Gastroenterology & Urology · 77d
Cleared Dec 09, 1987
MERITEC(TM)-GC
K874078 · LIC
Meridian Diagnostics, Inc.
Microbiology · 64d
Cleared Dec 09, 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
K874466 · JWY
Analytical Products, Inc.
Microbiology · 37d
Cleared Dec 09, 1987
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
K874650 · FKO
Quinton, Inc.
Gastroenterology & Urology · 26d
Cleared Dec 08, 1987
BESTCON/SPERMICIDE
K871451 · HIS
Europharmaceutical Corp.
Obstetrics & Gynecology · 239d
Cleared Dec 08, 1987
AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR
K872645 · LRB
Richards Medical Co., Inc.
Ear, Nose, Throat · 155d
Cleared Dec 08, 1987
KIMONO (CONDOMS)
K872799 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 146d
Cleared Dec 08, 1987
HEARING AID (ALL-IN-THE-EAR)
K873003 · ESD
Acoustical Hearing Services, Inc.
Ear, Nose, Throat · 126d
Cleared Dec 08, 1987
SERVICE MASTER (IMPULSE)
K873300 · LRB
Richards Medical Co., Inc.
Ear, Nose, Throat · 112d
Cleared Dec 08, 1987
NICOLET DIGITAL TWO PIECE HEARING AID
K873736 · ESD
Nicolet Biomedical Instruments
Ear, Nose, Throat · 84d
Cleared Dec 08, 1987
BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE
K873763 · LYC
Geistlich-Pharma
Dental · 83d
Cleared Dec 08, 1987
JDM SP2 SENSOR
K873806 · KMI
Jd Monitoring C/O Mackler, Cooper and...
General Hospital · 81d
Cleared Dec 08, 1987
MOTHER'S MILK BAG
K874071 · HGX
Yanase Waitch K.K.
Obstetrics & Gynecology · 63d
Cleared Dec 08, 1987
RIGID-LENS CASE
K874657 · LRX
Sola Ophthalmics
Ophthalmic · 19d