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
168481–168504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1979
AF/SYSTEM
K791192
Ariel
General & Plastic Surgery · 86d
Cleared Sep 19, 1979
VENTRICULAR LEAD, MODEL 6959
K790143 · DTB
Medtronic Vascular
Cardiovascular · 243d
Cleared Sep 19, 1979
DAHLBERG HEARING AID MODEL UN
K791311 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 65d
Cleared Sep 19, 1979
VA 1000
K791380 · DTA
Vitatron Medical BV
Cardiovascular · 57d
Cleared Sep 19, 1979
AMALGAMATOR MODEL SDC--
K791410 · EFD
Sierra Laboratories, Inc.
Dental · 69d
Cleared Sep 19, 1979
LINDE OXYGEN CONCENTRATOR LOC-II
K791437 · CAW
Union Carbide Corp.
Anesthesiology · 50d
Cleared Sep 19, 1979
BARD BIOMEDICAL NERVE LOCATOR
K791442 · BXN
C.R. Bard, Inc.
Anesthesiology · 60d
Cleared Sep 19, 1979
MODEL 344
K791506 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 47d
Cleared Sep 19, 1979
RESPIRATOR DISCONNECT ALARM CR201
K791527 · CAP
Intersect Medical Products, Inc.
Anesthesiology · 40d
Cleared Sep 19, 1979
OHIO MODULAR ANESTHESIA GAS MACHINE
K791530 · BSZ
Ohio Medical Products
Anesthesiology · 40d
Cleared Sep 19, 1979
RESPIRATOR DISCONNECT ALARM VA-100
K791561 · CAP
Intersect Medical Products, Inc.
Anesthesiology · 35d
Cleared Sep 19, 1979
IMPLANTABLE PULSE GENERATOR PACEMAKERS
K791568 · DXY
Intermedics, Inc.
Cardiovascular · 40d
Cleared Sep 19, 1979
MODEL G-61 ULTRASONIC DENTAL UNIT
K791585 · ELC
Cavitron Corp.
Dental · 33d
Cleared Sep 19, 1979
ROYCO MODEL 371 SUPER DILUTOR
K791644 · GKH
Royco Instruments
Hematology · 27d
Cleared Sep 19, 1979
SCOTTS SURGICAL RETRACTOR AND ELASTIC
K791665 · GAD
Lone Star Medical Products, Inc.
General & Plastic Surgery · 29d
Cleared Sep 19, 1979
ANGIOTENSIN CONVERTING ENZYME ASSAY SYS
K791712 · KQN
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared Sep 19, 1979
VICKERS MEDICAL MODEL 130 NEAVENT-NEO
K791713 · CBK
Vickers America Medical Corp.
Anesthesiology · 23d
Cleared Sep 19, 1979
IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC
K791732 · DTB
Oscor, Inc.
Cardiovascular · 14d
Cleared Sep 19, 1979
MEROCEL INSTRUMENT WIPE
K791736 · GEC
Xomed, Inc.
General & Plastic Surgery · 19d
Cleared Sep 19, 1979
MEDTRONIC MODEL 6957
K791769 · DTB
Medtronic Vascular
Cardiovascular · 14d
Cleared Sep 19, 1979
TUBE-STRAP
K791781 · JAY
Olympic Medical Corp.
Anesthesiology · 8d
Cleared Sep 19, 1979
CONPHAR AIRWAYS
K791799 · CAE
Conphar, Inc.
Anesthesiology · 6d
Cleared Sep 17, 1979
SPECTRA R PAD
K791013 · GYB
Parker Laboratories, Inc.
Neurology · 108d
Cleared Sep 17, 1979
ULTRASONIC DENTAL PROPHYLAXIS UNIT
K791024 · ELC
Litton Dental Products
Dental · 110d