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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86689–86712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1999
BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND...
K984613 · JOJ
Albert Browne , Ltd.
General Hospital · 37d
Cleared Feb 04, 1999
BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND...
K984616 · JOJ
Albert Browne , Ltd.
General Hospital · 37d
Cleared Feb 04, 1999
CLEARFIL SE BOND
K990040 · KLE
Kuraray Co.
Dental · 29d
Cleared Feb 04, 1999
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
K990197 · MEH
Exactech, Inc.
Orthopedic · 15d
Cleared Feb 03, 1999
NUMOBAG
K981949 · KPJ
Numotech, Inc.
General & Plastic Surgery · 245d
Cleared Feb 03, 1999
OPTICOAT T4 EIA KIT
K982298 · KLI
Biotecx Laboratories, Inc.
Chemistry · 217d
Cleared Feb 03, 1999
PRESSUREWIRE SENSOR, MODEL #12001
K983506 · DQX
Radi Medical Systems AB
Cardiovascular · 119d
Cleared Feb 03, 1999
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
K983509 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 119d
Cleared Feb 03, 1999
ENDOPATH ULTRA VERESS NEEDLE
K983925 · HIF
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 03, 1999
CERALAS DIODE LASER SYSTEM (MODEL H)
K983950 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 90d
Cleared Feb 03, 1999
EDI VERIS SYSTEM
K983983 · HLX
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 86d
Cleared Feb 03, 1999
PANORAMIC200 OPTHALMOSCOPE
K983999 · HLI
Optos Plc.
Ophthalmic · 86d
Cleared Feb 03, 1999
ABBOTT ARCHITECT B12
K984108 · LIG
Abbott Laboratories
Chemistry · 78d
Cleared Feb 03, 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL...
K984209 · HWC
Biomet, Inc.
Orthopedic · 71d
Cleared Feb 03, 1999
ADVANCED REVISION PRODUCT LINE EXTENSION
K990030 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Feb 03, 1999
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR
K990157 · IOR
Invacare Corp.
Physical Medicine · 15d
Cleared Feb 02, 1999
EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA
K980631 · DXC
Embol-X, Inc.
Cardiovascular · 349d
Cleared Feb 02, 1999
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
K981725 · BZQ
Optovent, Inc.
Anesthesiology · 263d
Cleared Feb 02, 1999
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
K982307 · JNB
Wallac, Inc.
Chemistry · 216d
Cleared Feb 02, 1999
MEROGEL NASAL DRESSING AND SINUS STENT
K982731 · EMX
Xomed, Inc.
Ear, Nose, Throat · 181d
Cleared Feb 02, 1999
OSTEOMARK NTX SERUM EIA
K983457 · JMM
Ostex Intl., Inc.
Chemistry · 125d
Cleared Feb 02, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC...
K983690 · MOI
Ortho-Clinical Diagnostics, Inc.
Immunology · 104d
Cleared Feb 02, 1999
ANTI-TPO EIA DIAGNOSTIC TEST KIT
K984163 · JZO
The Binding Site, Ltd.
Immunology · 74d
Cleared Feb 02, 1999
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
K984165 · JZO
The Binding Site, Ltd.
Immunology · 74d