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
68233–68256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2004
HC604 CPAP HUMIDIFIER
K041900 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 48d
Cleared Aug 31, 2004
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
K041901 · MWJ
North East Monitoring, Inc.
Cardiovascular · 48d
Cleared Aug 31, 2004
FABIUS GS ANESTHESIA SYSTEM
K042086 · BSZ
Draeger Medical, Inc.
Anesthesiology · 28d
Cleared Aug 31, 2004
GE DATEX-OHMEDA AISYS CARESTATION
K042154 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 21d
Cleared Aug 31, 2004
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
K042218 · NTE
Guidant Corp.
Cardiovascular · 26d
Cleared Aug 31, 2004
MULTI-DRIP INFUSION CATHETER
K042246 · MEB
Advanced Infusion, Inc.
General Hospital · 12d
Cleared Aug 31, 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
K042265 · DXN
Health & Life Co., Ltd.
Cardiovascular · 8d
Cleared Aug 31, 2004
ACCLAIM
K042266 · NRD
Air Techniques, Inc.
Dental · 8d
Cleared Aug 31, 2004
MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
K042273 · DXN
Health Hero Network, Inc.
Cardiovascular · 8d
Cleared Aug 30, 2004
CARRIAZO PENDULAR
K032910 · HNO
Schwind Eye-Tech-Solutions GmbH & Co. KG
Ophthalmic · 343d
Cleared Aug 30, 2004
EV APAN DIGITAL, MODEL K1VSM2000
K041120 · MUH
Afp Imaging Corp.
Radiology · 123d
Cleared Aug 30, 2004
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
K041657 · KQN
Thermo Electron Corporation
Chemistry · 73d
Cleared Aug 30, 2004
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
K041685 · DKZ
ACON Laboratories, Inc.
Toxicology · 69d
Cleared Aug 30, 2004
COMPOSITE/COMPOMER REPAIR KIT
K041960 · KLE
Dmg USA, Inc.
Dental · 40d
Cleared Aug 30, 2004
ORTHODONTIC CERAMIC BRACKETS
K042178 · NJM
Dentsply Intl.
Dental · 19d
Cleared Aug 30, 2004
VAPOTHERM MODEL#2000I, 200H
K042245 · BTT
Vapotherm, Inc.
Anesthesiology · 11d
Cleared Aug 27, 2004
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
K031502 · FIN
Usfilter
Gastroenterology & Urology · 472d
Cleared Aug 27, 2004
MYOHEALTH CLENCHING INHIBITOR
K040315 · MQC
Mci-Myohealth Systems
Dental · 200d
Cleared Aug 27, 2004
EXPANDABLE PEEK VBR IMPLANT
K040928 · MQP
Interpore Cross Intl.
Orthopedic · 140d
Cleared Aug 27, 2004
DURASUL BIPOLAR
K040947 · KWY
Centerpulse Orthopedics, Inc.
Orthopedic · 137d
Cleared Aug 27, 2004
SYNTHES (USA) TITANIUM WIRE
K041333 · GAQ
Synthes (Usa)
General & Plastic Surgery · 100d
Cleared Aug 27, 2004
ACCUSOL DIALYSIS SOLUTION
K041428 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Aug 27, 2004
BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM
K041508 · LLZ
Barco NV Barcoview
Radiology · 81d
Cleared Aug 27, 2004
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K041563 · LFD
Glaxosmithkline Consumer Healthcare,...
Dental · 78d