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
142513–142536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1986
URICMETER
K863113 · KNK
J. D. Assoc.
Chemistry · 27d
Cleared Sep 09, 1986
PERITONEAL DIALYSIS CATHETERS
K863128 · FJS
Thermedics, Inc.
Gastroenterology & Urology · 25d
Cleared Sep 09, 1986
MODEL AS-72 ADMINISTRATION SET
K863169 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 22d
Cleared Sep 09, 1986
BLOOD UREA NITROGEN(BUN) PROCEDURE
K863260 · CDQ
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Sep 09, 1986
SURGI-TEK TUBE POSITIONER
K863279
Dermacare Products, Inc.
General & Plastic Surgery · 15d
Cleared Sep 09, 1986
DERMAMARKER
K863280 · FZZ
Dermacare Products, Inc.
General & Plastic Surgery · 15d
Cleared Sep 09, 1986
DISPOSABLE SUCTION CANNULA NO. 902008-000
K863293 · GEA
Lifestream Int'L, Inc.
General & Plastic Surgery · 15d
Cleared Sep 09, 1986
MODIFIED Q50 MEDICAL TREADMILL
K863299 · IOL
Quinton, Inc.
Physical Medicine · 15d
Cleared Sep 09, 1986
GRIP STRENGTH DEVICE (GSD)
K863313 · IKK
Devcom, Inc.
Physical Medicine · 14d
Cleared Sep 08, 1986
TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD
K860830 · LIZ
Technicon Instruments Corp.
Hematology · 187d
Cleared Sep 08, 1986
SUTTER LESSER METATARSAL CAP
K861983 · KWD
Sutter Biomedical, Inc.
Orthopedic · 109d
Cleared Sep 08, 1986
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
K862189 · LGD
Organon Teknika Corp.
Microbiology · 91d
Cleared Sep 08, 1986
CIBA CORNING MAGIC LITE ANALYZER
K862235 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 89d
Cleared Sep 08, 1986
DAS 211
K862593
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Sep 08, 1986
TINA-QUANT(R) IGM
K862762 · DFT
Boehringer Mannheim Corp.
Immunology · 48d
Cleared Sep 08, 1986
HALL CANNLULA SYSTEM
K862778 · HRX
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 48d
Cleared Sep 08, 1986
125-I TSH RECEPTOR ANTIBODY KIT
K863006 · JZO
Cronus
Immunology · 31d
Cleared Sep 08, 1986
US PLUS-PAK(R) SURGICAL SYSTEM
K863209 · HQC
Ipax, Inc.
Ophthalmic · 19d
Cleared Sep 05, 1986
OMF-7101 FETAL MONITOR
K860237 · HGM
Nihon Kohden America, Inc.
Obstetrics & Gynecology · 225d
Cleared Sep 05, 1986
SYRINGE INFUSION PUMP
K860353 · FRN
Travenol Laboratories, S.A.
General Hospital · 218d
Cleared Sep 05, 1986
DUMBACH TITANIUM MESH IMPLANT SYSTEM
K862532 · JEY
Walter Lorenz Surgical, Inc.
Dental · 65d
Cleared Sep 05, 1986
PHOTO CLEARFIL BRIGHT
K862942 · EBF
Kuraray Co.
Dental · 31d
Cleared Sep 05, 1986
FLEXICAIR
K863047 · IOQ
Ssi Medical Services, Inc.
Physical Medicine · 24d
Cleared Sep 05, 1986
BOWEN SUTURE PASSER
K863146 · HXI
Bowen & Company, Inc.
Orthopedic · 21d