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
123673–123696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1990
XCALIBER
K904818 · ITI
Everest & Jennings, Inc.
Physical Medicine · 14d
Cleared Nov 07, 1990
HANDI-TRAK WHEELCHAIR SNOW CHAINS
K904913 · KNN
Handi-Trak, Inc.
Physical Medicine · 7d
Cleared Nov 06, 1990
SIEMEN'S SIREMOBILE II C-ARM
K902983 · JAA
Electromek Diagnostic Systems, Inc.
Radiology · 133d
Cleared Nov 06, 1990
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
K903441 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 98d
Cleared Nov 06, 1990
CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
K903560 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 90d
Cleared Nov 06, 1990
ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.
K903582 · LIT
Catheter Sciences Co.
Cardiovascular · 90d
Cleared Nov 06, 1990
REFLOTRON POTASSIUM TEST TABS
K904033 · CEJ
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Nov 06, 1990
DUPONT SALICYLATE CALIBRATOR
K904307 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 48d
Cleared Nov 06, 1990
BIOCLONES ELEGANCE LH ELISA KIT
K904387 · CEP
Bioclone Australia Pty , Ltd.
Chemistry · 42d
Cleared Nov 06, 1990
RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235
K904623 · IXQ
Atomic Products Corp.
Radiology · 26d
Cleared Nov 06, 1990
QMS TM- PHENYTOIN
K904815 · DIP
Seradyn, Inc.
Chemistry · 13d
Cleared Nov 05, 1990
NELATON-, FEMALE - OR TIEMANN CATHETER
K896729 · KOD
Unoplast A/S
Gastroenterology & Urology · 340d
Cleared Nov 05, 1990
MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
K900720 · DSI
Mortara Instrument, Inc.
Cardiovascular · 264d
Cleared Nov 05, 1990
WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC
K901015 · DPW
Wright Medical Corp.
Cardiovascular · 245d
Cleared Nov 05, 1990
MONOHAEM (FECAL OCCULT BLOOD TEST)
K901064 · KHE
Silenus Laboratories Proprietary , Ltd.
Hematology · 243d
Cleared Nov 05, 1990
TSRH SACRAL L-CONNECTOR
K901587 · KWP
Danek Medical, Inc.
Orthopedic · 215d
Cleared Nov 05, 1990
SAFEBRIS STERILE CIRCUMCISION KIT
K902119 · FHJ
Kedumin Kits, Ltd.
Obstetrics & Gynecology · 180d
Cleared Nov 05, 1990
MODULOCK POSTERIOR SPINAL FIXATION
K902397 · KWP
Zimmer, Inc.
Orthopedic · 159d
Cleared Nov 05, 1990
CDI (TM) SYSTEM 100 MONITORING SYSTEM
K902654 · DTY
3M Health Care, Ltd.
Cardiovascular · 143d
Cleared Nov 05, 1990
ARTERIAL BLOOD SAMPLING KIT
K902771 · DQO
Medex, Inc.
Cardiovascular · 137d
Cleared Nov 05, 1990
BACTTRAP
K903056 · CAH
Pharma Systems, Inc.
General Hospital · 117d
Cleared Nov 05, 1990
CHANLLENGE 1010 PATIENT KEY PROGRAM STATION
K903149 · IPF
Maximum Performance Technologies,...
Physical Medicine · 110d
Cleared Nov 05, 1990
SOLARSHIELDS ENCORE
K903487 · HQY
Dioptics
Ophthalmic · 97d
Cleared Nov 05, 1990
ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.
K903555 · DRX
Jason Marketing Co.
Cardiovascular · 90d