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
67801–67824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2004
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · DCK
Stanbio Laboratory
Immunology · 164d
Cleared Oct 14, 2004
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · LHI
B.Braun Medical, Inc.
General Hospital · 157d
Cleared Oct 14, 2004
HEMOVAC BLOOD REINFUSION SYSTEM
K041525 · CAC
Zimmer, Inc.
Anesthesiology · 128d
Cleared Oct 14, 2004
EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001
K041530 · NHN
Stargate International, Inc.
Physical Medicine · 128d
Cleared Oct 14, 2004
AESKULISA DS DNA G
K041628 · LSW
Aesku Diagnostics
Immunology · 120d
Cleared Oct 14, 2004
APNEA RISK EVALUATION SYSTEM (ARES)
K041662 · MNR
Advanced Brain Monitoring, Inc.
Anesthesiology · 118d
Cleared Oct 14, 2004
XTRAC XL, MODEL AL8000
K041943 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 87d
Cleared Oct 14, 2004
PRESS TACK NEEDLE
K042063 · MQX
Asia-Med GmbH & Co. Kg. - Werk Suhl
General Hospital · 73d
Cleared Oct 14, 2004
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K042336 · JPK
Bio-Rad Laboratories, Inc.
Hematology · 45d
Cleared Oct 14, 2004
NYLON THREADED NEEDLE
K042367 · GAR
Aros Surgical Instruments Corp.
General & Plastic Surgery · 44d
Cleared Oct 14, 2004
PAINPUMP1
K042405 · FRN
Stryker Corp.
General Hospital · 41d
Cleared Oct 14, 2004
3 SERIES PHOTOTHERAPY CABINET
K042502 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 30d
Cleared Oct 14, 2004
TRANSDERM IONTO SYSTEM, MK 2
K042590 · EGJ
Mattioli Engineering Corp.
Physical Medicine · 21d
Cleared Oct 14, 2004
SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024...
K042667 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 15d
Cleared Oct 13, 2004
FOUNDATION
K040783 · LYC
Terumo Corp.
Dental · 201d
Cleared Oct 13, 2004
MB 105 MILLENNIUM BLADES
K041110 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 168d
Cleared Oct 13, 2004
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED...
K042271 · JWH
Zimmer, Inc.
Orthopedic · 51d
Cleared Oct 13, 2004
AMLUCK, YA HORNG
K042581 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 21d
Cleared Oct 13, 2004
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
K042655 · CAF
Respironics New Jersey, Inc.
Anesthesiology · 15d
Cleared Oct 13, 2004
CDX DIGITAL X-RAY IMAGING SYSTEM
K042736 · MUH
Cnc Imaging, Inc.
Radiology · 12d
Cleared Oct 13, 2004
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
K042742 · MXK
Heidelberg Engineering
Ophthalmic · 9d
Cleared Oct 12, 2004
KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND...
K031728 · DWJ
Klimamed Technologie Medizingerate GmbH
Cardiovascular · 496d
Cleared Oct 12, 2004
COULTER A T 5DIFF CAP PIERCE (CP)
K042173 · GKZ
Beckman Coulter, Inc.
Hematology · 62d
Cleared Oct 12, 2004
ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
K042501 · DQA
Hitachi Medical Corp.
Anesthesiology · 28d