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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
42841–42864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2012
SMARTSTITCH PERFECTPASSER SYSTEM
K123268 · GAT
Arthocare Corporation
General & Plastic Surgery · 19d
Cleared Nov 06, 2012
INSURGICAL SINGLE USE POWER EQUIPMENT
K112599 · KIJ
Insurgical, LLC
Orthopedic · 426d
Cleared Nov 06, 2012
NYLUS PICC
K113225 · LJS
Semprus Biosciences
General Hospital · 371d
Cleared Nov 06, 2012
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
K120466 · NTI
Nanosphere, Inc.
Toxicology · 265d
Cleared Nov 06, 2012
TRINITY WRINKLE REMOVER
K120560 · OHS
Carol Cole Company
General & Plastic Surgery · 256d
Cleared Nov 06, 2012
HU-FRIEDY DENTAL CARTRIDGE SYRINGE
K120659 · EJI
Hu-Friedy Mfg. Co., LLC
Dental · 246d
Cleared Nov 06, 2012
VRESELECT CULTURE MEDIUM
K122187 · JSO
Bio-Rad
Microbiology · 105d
Cleared Nov 06, 2012
BLUE POWDERED NITRILE EXAMINATION GLOVE
K122998 · LZA
Northstar Healthcare Holdings
General Hospital · 40d
Cleared Nov 05, 2012
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
K120280 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 280d
Cleared Nov 05, 2012
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
K121434 · LNH
Siemens Medi Cal Solutions, Inc.
Radiology · 175d
Cleared Nov 05, 2012
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
K121509 · KWY
Tgm Medical, Inc.
Orthopedic · 168d
Cleared CT Nov 05, 2012
ALTIS SINGLE INCISION CLING SYSTEM
K121562 · PAH
Coloplast A/S
Gastroenterology & Urology · 160d
Cleared Nov 05, 2012
MINIME 2 NASAL MASK
K121692 · BZD
Sleepnet Corporation
Anesthesiology · 151d
Cleared Nov 05, 2012
DYMAXEON SPINE SYSTEM
K121786 · NKB
B2b Spine Pty, Ltd.
Orthopedic · 140d
Cleared CT Nov 05, 2012
THE ABLATION SYSTEM
K121858 · HFG
Halt Medical, Inc.
Obstetrics & Gynecology · 132d
Cleared Nov 05, 2012
FLEXIPORT ECOCUFF
K122058 · DXQ
Welch Allyn, Inc.
Cardiovascular · 115d
Cleared Nov 05, 2012
VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION...
K122425 · GEI
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 88d
Cleared Nov 05, 2012
CS2 HIP SYSTEM
K122512 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 80d
Cleared Nov 05, 2012
OSOM INFLUENZA A&B TEST MODEL 190
K123182 · GNX
SEKISUI Diagnostics, LLC
Microbiology · 26d
Cleared Nov 02, 2012
IUI CATHETERS
K112396 · MQF
Kitazato Medical Co., Ltd.
Obstetrics & Gynecology · 441d
Cleared Nov 02, 2012
TAMARIN BLUE PTCA RX DILATATION CATHETER
K112735 · LOX
Natec Medical , Ltd.
Cardiovascular · 409d
Cleared Nov 02, 2012
LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
K120555 · HIS
Medical-Latex (Dua) Sdn. Bhd
Obstetrics & Gynecology · 253d
Cleared Nov 02, 2012
RESUSCITAIRE WITH AUTOBREATH
K120642 · FMT
Draeger Medical Systems, Inc.
General Hospital · 245d
Cleared Nov 02, 2012
EC 2.7 ENDOSCOPIC CUTTER
K120909 · GEI
Medtronic Advanced Energy, LLC
General & Plastic Surgery · 221d