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
157561–157584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1983
ENDOMET
K830117 · EMA
North Pacific Dental, Inc.
Dental · 49d
Cleared Mar 01, 1983
DENSITOMETRIC INHALENT PROFILE SLLER
K830164 · DGC
Mast Immunosystems
Immunology · 42d
Cleared Mar 01, 1983
FOCUS FLUID
K830187 · EIF
Hematology Marketing Assoc.
Hematology · 41d
Cleared Mar 01, 1983
OSMOCEL +
K830188 · GIF
Hematology Marketing Assoc.
Hematology · 41d
Cleared Mar 01, 1983
NON-STERILE BROVIAC PARENTERAL ALIMI-
K830256 · LJS
Evermed, Inc.
Microbiology · 35d
Cleared Mar 01, 1983
FREHAN INC. I.V. FILTER HOLDER
K830300 · KMK
Saxnor Corp.
General Hospital · 32d
Cleared Mar 01, 1983
TIGER PULSE
K830325 · GZK
Bertone & Assoc.
Neurology · 28d
Cleared Mar 01, 1983
SECURA IV VOLUMETRIC INFUSION PUMP
K830355 · FRN
Diatek, Inc.
General Hospital · 26d
Cleared Mar 01, 1983
3M OSTEOTOMY GUIDE
K830360 · HWT
3M Company
Orthopedic · 26d
Cleared Mar 01, 1983
SECURA SET PRIMARY ADMIN. SET
K830377 · FPA
Diatek, Inc.
General Hospital · 25d
Cleared Mar 01, 1983
NON-STERILE CATHETER REPAIR KITS
K830406 · LJS
Evermed, Inc.
Microbiology · 22d
Cleared Mar 01, 1983
DELMED IV CONTAINER
K830450 · KPE
Delmed, Inc.
General Hospital · 14d
Cleared Feb 28, 1983
CHECK MATE #1850 ELEC. DIGITAL THERMO
K823493 · FLL
Bristoline, Inc.
General Hospital · 97d
Cleared Feb 28, 1983
MANUALISA MICROTITRATION PLATE READER
K823590 · JJQ
Ortho Diagnostic Systems, Inc.
Chemistry · 84d
Cleared Feb 28, 1983
EPI CARDIA SYS. - AMBULATORY MONITOR
K830013 · DSI
Medicomp, Inc.
Cardiovascular · 56d
Cleared Feb 28, 1983
HARVARD APPARATUS INTERMITTENT INFUSION
K830102 · FRN
C.R. Bard, Inc.
General Hospital · 48d
Cleared Feb 28, 1983
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
K830149 · DWD
Instrumentation Laboratory CO
Chemistry · 42d
Cleared Feb 28, 1983
VEINPREP VEIN GRAFT PREP. KIT A277723
K830150 · DWD
Atrium Medical Corp.
Cardiovascular · 42d
Cleared Feb 28, 1983
RICHARDS INTRA-ARTICULAR SHAVER BLADES
K830153 · GEY
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 41d
Cleared Feb 28, 1983
REFEREE BLOOD GAS ANALYZER CONTROLS
K830181 · JJS
Analytical Products, Inc.
Chemistry · 41d
Cleared Feb 28, 1983
LYSIS +
K830186 · GGK
Hematology Marketing Assoc.
Pathology · 40d
Cleared Feb 28, 1983
NON-STERILE,SINGLE/SOUBLE LUMEN-CATH
K830233 · LJS
Evermed, Inc.
General Hospital · 34d
Cleared Feb 28, 1983
CVT VIRAL TRANSPORTS
K830250 · JTW
Immulok, Inc.
Microbiology · 34d
Cleared Feb 28, 1983
CAMPY BLOOD AGAR PLATE
K830251 · JSI
Granite Diagnostics, Inc.
Microbiology · 34d