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
162265–162288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1982
SCOTCHBOND DENTAL ADHESIVE
K813180 · KLE
3M Company
Dental · 61d
Cleared Jan 12, 1982
CRITIKON I.V. CATHETER PLACEMENT UNIT
K813345 · FOZ
Critikon Company, LLC
General Hospital · 48d
Cleared Jan 12, 1982
VERSCHLUBSTOPFEN COMB-CLOSING STOPPER
K813396 · FOZ
Burron Medical Products, Inc.
General Hospital · 39d
Cleared Jan 12, 1982
WA-2000 TEMPERATURE INDICATOR
K813402 · FLL
Wallach Surgical Devices, Inc.
General Hospital · 39d
Cleared Jan 12, 1982
ELECTROSURGICAL DISP. DISPERSIVE PAD
K813434 · KNS
Promedicon, Inc.
Gastroenterology & Urology · 35d
Cleared Jan 12, 1982
UNIT, LIQUID, OXYGEN, PORTABLE
K813453 · BYJ
Pensee Medical Corp.
Anesthesiology · 33d
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