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

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176,076 results
155257–155280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1984
AMBULATORY MONITORING DEVICE
K833162 · DSI
Oxford Medilog, Inc.
Cardiovascular · 116d
Cleared Jan 10, 1984
SENTINEL SYSTEMS
K833395 · DXG
Quantitative Medicine, Inc.
Cardiovascular · 102d
Cleared Jan 10, 1984
SYRINGE
K833399 · FMF
I M, Inc.
General Hospital · 97d
Cleared Jan 10, 1984
BDH UNIPOLAR FEMORAL COMPONENT A2
K833403 · KWL
Carbomedics, Inc.
Orthopedic · 102d
Cleared Jan 10, 1984
KINETIX MOUTHPIECE
K833420 · BYP
Kinetix
Anesthesiology · 99d
Cleared Jan 10, 1984
REMOLDABLE CRANIOMANDIBULAR APPLIANCE
K833455 · KMY
Jeffrey H. Attlin
Dental · 105d
Cleared Jan 10, 1984
COAXIAL VOL. VENTILATOR CIRCUIT
K833459 · BZO
Airco/Ohio Medical Products
Anesthesiology · 97d
Cleared Jan 10, 1984
DIATEK 600 THERMOMETER SYSTEM
K833568 · FLL
Diatek, Inc.
General Hospital · 90d
Cleared Jan 10, 1984
COULTER COUNTER MODEL S-PLUS V
K833600 · GKZ
Coulter Electronics, Inc.
Hematology · 90d
Cleared Jan 10, 1984
DENTAL RUBBERDAM
K833610 · EIE
Center For Marketing Services
Dental · 89d
Cleared Jan 10, 1984
STERILE OIL AND GUIDEWIRE
K833671 · HNL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Jan 10, 1984
LP200 & HP800 SERIES VASCULAR PROSTH
K833716 · DSY
Intervascular, Inc.
Cardiovascular · 81d
Cleared Jan 10, 1984
STERILIZATION OF GORE-TEX SOFT TISSU
K833764 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 76d
Cleared Jan 10, 1984
MULTI-LUMEN INTRAVENOUS INFUSION CATH
K833825 · DQY
Medical Parameters, Inc.
Cardiovascular · 69d
Cleared Jan 10, 1984
HEPARIN COATED BALLOON THERMODILU
K834036 · DYG
Nova Medical Specialties
Cardiovascular · 48d
Cleared Jan 10, 1984
HEPARIN COATED BALLOON THERMODILU
K834037 · DYG
Nova Medical Specialties
Cardiovascular · 48d
Cleared Jan 10, 1984
SLO-FLO 40AL ADJUST-FLOW REGULATOR
K834061 · CAN
S.L.O. Health Products, Inc.
Anesthesiology · 46d
Cleared Jan 10, 1984
MEDELA APGAR TIMER
K834129 · LHB
Medela, Inc.
General Hospital · 41d
Cleared Jan 10, 1984
BONE PLUGGING TOOL
K834229 · HTW
Standard Surgical
Orthopedic · 35d
Cleared Jan 10, 1984
RECON-2 FLOW CONTROLLER
K834260 · CAX
Precision Metering, Inc.
Anesthesiology · 34d
Cleared Jan 10, 1984
DIGITAL RADIOGRAPHY SYS-DPS7100
K834287 · JAA
Adac Laboratories
Radiology · 46d
Cleared Jan 10, 1984
MULTITREAT 48
K834308 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 67d
Cleared Jan 10, 1984
APO A-I RIA KIT-HUMAN PLASMA APOLIP-
K840105
Iso-Tex Diagnostics
Chemistry
Cleared Jan 09, 1984
MEDICALEX
K831728 · FQM
Medicalex
General Hospital · 223d