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
126817–126840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1990
INTRAVASCULAR IMAGING SYSTEM
K895159 · LYK
Intertherapy, Inc.
Cardiovascular · 201d
Cleared Mar 12, 1990
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM
K895915 · MCB
Meridian Diagnostics, Inc.
Microbiology · 153d
Cleared Mar 12, 1990
INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
K896923 · CAF
Intertech Resources, Inc.
Anesthesiology · 90d
Cleared Mar 12, 1990
HOOD SPEAKING VALVE
K897059 · JOH
Hood Laboratories
Anesthesiology · 84d
Cleared Mar 12, 1990
POLY G PHYSIOLOGICAL DATA RECORDER
K897107 · BXO
Cns, Inc.
Anesthesiology · 81d
Cleared Mar 12, 1990
LASER IMAGING WORK STATION
K897186 · HJI
Innovision Medical, Inc.
Ophthalmic · 74d
Cleared Mar 12, 1990
NIKON MULTI-SPORT SUNGLASSES
K900090 · HQY
Oculus America
Ophthalmic · 66d
Cleared Mar 12, 1990
MOBILIMB W1 WRIST CPM UNIT
K900466 · BXB
Toronto Medical Corp.
Physical Medicine · 40d
Cleared Mar 12, 1990
MODIFIED COATRON II AND COATRON JR.
K900506 · JPA
Astral Medical Systems
Hematology · 38d
Cleared Mar 12, 1990
MOBILIMB L4 LOWER LIMB CPM UNIT
K900795 · BXB
Toronto Medical Corp.
Physical Medicine · 20d
Cleared Mar 12, 1990
MODIFIED AML + ACETABULAR CUP PROSTHESIS
K900891 · JDI
Depuy, Inc.
Orthopedic · 13d
Cleared Mar 09, 1990
PATIENT EXAMINATION GLOVES
K893606 · LZA
Aukland Mfg., Inc.
General Hospital · 303d
Cleared Mar 09, 1990
NICOLET BEAM II SYSTEM
K894629 · GWS
Nicolet Instrument Corp.
Neurology · 228d
Cleared Mar 09, 1990
MAGNETIC RESONANCE SYSTEM MODEL BMT-1100
K895328 · LNH
Bruker Medical Imaging, Inc.
Radiology · 190d
Cleared Mar 09, 1990
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
K895479 · BYH
Thayer Medical Corp.
Anesthesiology · 179d
Cleared Mar 09, 1990
ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
K895781 · LZC
Ansell Intl.
General Hospital · 163d
Cleared Mar 09, 1990
BIOPSY FORCEPS, (NON-RIGID)
K896146 · EOQ
Portlyn Corp.
Ear, Nose, Throat · 137d
Cleared Mar 09, 1990
AG-820PA FI02 MODULE
K896359 · CCL
Nihon Kohden America, Inc.
Anesthesiology · 123d
Cleared Mar 09, 1990
AIA-PACK T4
K896982 · KLI
Tosoh Corp.
Chemistry · 80d
Cleared Mar 09, 1990
PARI I.S.-2
K896984 · CAF
Dura Pharmaceuticals, Inc.
Anesthesiology · 88d
Cleared Mar 09, 1990
TOSOH AIA-PACK T3
K897001 · CDP
Tosoh Corp.
Chemistry · 81d
Cleared Mar 09, 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 77d
Cleared Mar 09, 1990
AFFINITY(TM) HTSH(TM)
K897138 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 09, 1990
COULTER TRIGLYCERIDES GPO REAGENT
K897159 · CDT
Coulter Electronics, Inc.
Chemistry · 71d