Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
158401–158424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1983
VASCULAR-ACCESS-PORT
K830000 · LJT
Norfolk Medical Products, Inc.
General Hospital · 57d
Cleared Mar 01, 1983
INTRAMEDULLARY ROD
K830087 · HSB
The Deca Co.
Orthopedic · 49d
Cleared Mar 01, 1983
VITATHYL
K830105 · EAT
North Pacific Dental, Inc.
Dental · 49d
Cleared Mar 01, 1983
CIMPAT
K830109 · EMR
North Pacific Dental, Inc.
Dental · 49d
Cleared Mar 01, 1983
GUTTA PERCHA POINTS
K830114 · EKM
North Pacific Dental, Inc.
Dental · 49d
Cleared Mar 01, 1983
PAPER POINTS
K830115 · EKM
North Pacific Dental, Inc.
Dental · 49d
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