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
114121–114144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1993
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · DRX
Medtronic Vascular
Cardiovascular · 372d
Cleared Mar 18, 1993
ATTIC DEFECT PLATE
K921433 · ETC
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 358d
Cleared Mar 18, 1993
VASECTOMY DRAPE
K921657 · KKX
Graham Medical Products
General Hospital · 345d
Cleared Mar 18, 1993
ANGEION IGITAL ANGEFLATOR
K921757 · MAV
Angeion Corp.
Cardiovascular · 339d
Cleared Mar 18, 1993
SHAWNEE PRODUCTS KIT II
K921761 · KGX
Absentee Shawnee Bandage Group
General & Plastic Surgery · 338d
Cleared Mar 18, 1993
DISSECTION INSTRUMENT
K922094 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 317d
Cleared Mar 18, 1993
4 SURE TM NASAL OXYGEN CANNULA
K922397 · CAT
Boston Pacific Medical, Inc.
Anesthesiology · 301d
Cleared Mar 18, 1993
HPM 40 HEART PACEMAKER MONITOR
K922742 · KRE
Biotronik, GmbH & Co.
Cardiovascular · 283d
Cleared Mar 18, 1993
HANDTYMP
K923072 · ETY
Life-Tech Intl., Inc.
Ear, Nose, Throat · 266d
Cleared Mar 18, 1993
FUNNEL ADAPTOR
K923265 · CAD
Southmedic, Inc.
Anesthesiology · 259d
Cleared Mar 18, 1993
OPHTHALMIC PHARCO NEEDLE
K923725 · HQC
Synergetics, Inc.
Ophthalmic · 234d
Cleared Mar 18, 1993
AUGUSTA VALENTINI
K923884 · HQZ
Revue Intl.
Ophthalmic · 268d
Cleared Mar 18, 1993
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K923931 · GZB
Medtronic Vascular
Neurology · 225d
Cleared Mar 18, 1993
O.R. CONCEPTS SECONDARY CANNULA
K924022 · GCJ
O.R. Concepts, Inc.
General & Plastic Surgery · 219d
Cleared Mar 18, 1993
CORNEAL ANALYSIS SYSTEMS(TM)
K924032 · HQY
Eyesys Laboratories, Inc.
Ophthalmic · 219d
Cleared Mar 18, 1993
B-D PEN NEEDLE
K924070 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 218d
Cleared Mar 18, 1993
MAR-MED LIVER STRAP
K924223 · GDJ
Mar-Med Co.
General & Plastic Surgery · 209d
Cleared Mar 18, 1993
DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER
K924297 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 204d
Cleared Mar 18, 1993
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338 · DRC
Arrow Intl., Inc.
Cardiovascular · 203d
Cleared Mar 18, 1993
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
K924522 · GZB
Medtronic Vascular
Neurology · 191d
Cleared Mar 18, 1993
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
K924857 · DHX
Tosoh Medics, Inc.
Immunology · 171d
Cleared Mar 18, 1993
NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)
K925130 · GEI
Laserscope
General & Plastic Surgery · 156d
Cleared Mar 18, 1993
TRIANGULAR JAW MICROLARYNGEAL FORCEPS
K925370 · ELW
Pilling Co.
Dental · 146d
Cleared Mar 18, 1993
THERA PULSE A ELECTRO NERVE STIMULATOR
K925686 · GZJ
Biomedical Life Systems, Inc.
Neurology · 126d