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
161425–161448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1982
MAXILL-AIR SINUS VENTILATION TUBE
K813474 · KAM
Xomed, Inc.
General & Plastic Surgery · 42d
Cleared Jan 12, 1982
INFALERT
K813507 · BZQ
Briox Technologies, Inc.
Anesthesiology · 28d
Cleared Jan 12, 1982
CARDIOSONIC ACOUSTIC AMPLIFIER
K813510 · LDE
Srs Co.
Cardiovascular · 28d
Cleared Jan 12, 1982
IMPLANT AID SPLICING CRIMP & SLEEVE
K813518 · KFJ
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jan 12, 1982
FECAL SANITARY TUBE
K813526 · KNT
Leon'S Fecal Sanitary Tub Mfg.
Gastroenterology & Urology · 27d
Cleared Jan 12, 1982
DINAMAP ADULT/PED./NEONATAL VITAL SIGNS
K813527 · DXN
Critikon Company, LLC
Cardiovascular · 27d
Cleared Jan 12, 1982
LENS-PAC
K813528 · HPX
The Plactory
Ophthalmic · 26d
Cleared Jan 12, 1982
URIFIX
K813537 · KNX
Isramed, Inc.
Gastroenterology & Urology · 25d
Cleared Jan 12, 1982
AMIKACIN FLUORESCENT IMMUNOASSAY
K813541 · KLQ
American Diagnostic Corp.
Toxicology · 22d
Cleared Jan 12, 1982
TOBRAMYCIN FLUORESCENT IMMUNOASSAY
K813542 · LCR
American Diagnostic Corp.
Toxicology · 22d
Cleared Jan 12, 1982
HYPOSERMIC NEEDLES
K813545 · FMI
Optical Micro Systems, Inc.
General Hospital · 22d
Cleared Jan 12, 1982
RIONET HEARING AID HI-62
K813546 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 12, 1982
CONTINUOUS FLUSH DEVICE
K813549 · DRS
Namic
Cardiovascular · 22d
Cleared Jan 12, 1982
ACE/KYLE CAPTURED HIP SCREW
K813554 · KTT
Ace Orthopedic Manufacturing Co.
Orthopedic · 21d
Cleared Jan 12, 1982
TECHMEDIA BONE STAPLE
K813567 · JDR
Techmedica, Inc.
Orthopedic · 21d
Cleared Jan 12, 1982
PHONIC EAR MODEL PE805CD
K813583 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 12, 1982
CLINITRON AIR FLUIDIZED SUPPORT SYSTEM
K813584 · INX
Uhi Corp.
Physical Medicine · 15d
Cleared Jan 12, 1982
DISPOSABLE THORACIC CATHETER
K813587 · GBS
Texas Medical Products, Inc.
General & Plastic Surgery · 15d
Cleared Jan 08, 1982
WOUND CLOSURE INSTRUMENT TRAY
K812133 · FSM
E.M. Adams
General & Plastic Surgery · 164d
Cleared Jan 08, 1982
PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY
K813335 · FSH
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 45d
Cleared Jan 07, 1982
EAST-FREEMAN VENTILATOR MARK 2
K812958 · CBK
Cairco , Ltd.
Anesthesiology · 78d
Cleared Jan 07, 1982
THE CHICAGO GULLET
K813132 · KNT
Universal Prosthetics, Inc.
Gastroenterology & Urology · 63d
Cleared Jan 07, 1982
YOSHIDA RIDO-F, MODEL LM-01
K813348 · EKX
Kaycor Intl., Ltd.
Dental · 41d
Cleared Jan 07, 1982
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
K813352 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 41d