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
125737–125760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1990
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
K901362 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 75d
Cleared Jun 06, 1990
EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B
K901573 · DKB
Syva Co.
Toxicology · 63d
Cleared Jun 06, 1990
PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE
K901796 · ISA
Component Equipment Mfg., Inc.
Physical Medicine · 48d
Cleared Jun 06, 1990
REP(R) IMMUNOFIX
K901805 · DAH
Helena Laboratories
Immunology · 47d
Cleared Jun 06, 1990
SUPER STRENGTH DENTURE ADHESIVE CREAM
K901938 · KOB
Teledyne Getz
Gastroenterology & Urology · 37d
Cleared Jun 06, 1990
BLOOD GAS CONTROLS
K901985 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 35d
Cleared Jun 06, 1990
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
K901997 · IZH
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 35d
Cleared Jun 06, 1990
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
K902123 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jun 06, 1990
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
K902266 · JJR
Phoenix Diagnostics, Inc.
Chemistry · 16d
Cleared Jun 05, 1990
CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
K896648 · HSX
Concept, Inc.
Orthopedic · 193d
Cleared Jun 05, 1990
LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE
K896850 · LZO
Lima Intl. Corp.
Orthopedic · 182d
Cleared Jun 05, 1990
IRRIGATION AND SUCTION APPARATUS
K900430 · JCX
Acorn Group, Inc.
General & Plastic Surgery · 126d
Cleared Jun 05, 1990
LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.
K901128 · GEX
Lasercomp
General & Plastic Surgery · 85d
Cleared Jun 05, 1990
EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS
K901204 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 83d
Cleared Jun 05, 1990
L.M.S. SELF-DETACHABLE BROACH WITH STOP
K901273 · HTY
Med-Tek Corp.
Orthopedic · 78d
Cleared Jun 05, 1990
HORIZON SURGICAL LIGATING AND MARKING CLIP
K901303 · DSS
Horizon Surgical, Inc.
Cardiovascular · 77d
Cleared Jun 05, 1990
GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II
K901369 · KGN
Sterling Drug, Inc.
General & Plastic Surgery · 74d
Cleared Jun 05, 1990
SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
K901429 · OCY
Telemed Systems, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 04, 1990
CONDOM (RUBBER) CONTRACEPTIVE
K901416 · HIS
Aladan Corp.
Obstetrics & Gynecology · 70d
Cleared Jun 01, 1990
CT-1000A SYSTEM
K896779 · FLL
Bio-Monitor, Inc.
General Hospital · 182d
Cleared Jun 01, 1990
ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)
K896998 · MCH
S.P.K. Technology, Inc.
General & Plastic Surgery · 171d
Cleared Jun 01, 1990
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
K900488 · EJF
American Orthodontics
Dental · 122d
Cleared Jun 01, 1990
LATEX EXAMINATION GLOVES
K900980 · LYY
Sinochem (Usa), Inc.
General Hospital · 91d
Cleared Jun 01, 1990
ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
K901084 · KXO
Healthdyne Cardiovascular, Inc.
Obstetrics & Gynecology · 86d