FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
135865–135888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1988
TOSHIBA DIGITAL CLINICAL THERMOMETER
K881909 · FLL
Toshiba Glass Co., Ltd.
General Hospital · 20d
Cleared May 26, 1988
HIP SAVER
K882090 · INN
Pride Health Care, Inc.
Physical Medicine · 7d
Cleared May 26, 1988
STAIR VEYOR
K882091 · ILK
Pride Health Care, Inc.
Physical Medicine · 7d
Cleared May 25, 1988
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · DYG
Abbott Laboratories
Cardiovascular · 208d
Cleared May 25, 1988
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875178 · DTB
Intermedics, Inc.
Cardiovascular · 160d
Cleared May 25, 1988
HEPARIN COATED LUMINAL PACING CATHETER
K875337 · DQO
Spectramed, Inc.
Cardiovascular · 147d
Cleared May 25, 1988
MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
K880231 · DQT
Ideas For Medicine, Inc.
Cardiovascular · 133d
Cleared May 25, 1988
NIDEK CV-4000
K880929 · HQE
Nidek, Inc.
Ophthalmic · 82d
Cleared May 25, 1988
LASER OPTICAL CATHETER SYSTEM
K880991 · HHR
Medline Industries, Inc.
Obstetrics & Gynecology · 78d
Cleared May 25, 1988
INTERTECH STERILE WATER FOR INHALATION
K881184 · BTT
Delmed, Inc.
Anesthesiology · 65d
Cleared May 25, 1988
SPECTACLE, FRAME AND SUNGLASSES
K881278 · HQY
Nouvelle Ligne Paris
Ophthalmic · 61d
Cleared May 25, 1988
STUART CANNULATED CANCELLOUS BONE FIXATION SCREW
K881327 · HWC
Stuart Drug & Surgical Supply, Inc.
Orthopedic · 56d
Cleared May 25, 1988
PLASTIC FRAME & LENS SUNGLASS
K881419 · HQY
Marketing Innovations Intl., Inc.
Ophthalmic · 51d
Cleared May 25, 1988
MODEL 3487A PISCES EPIDURAL LEAD
K881491 · GZB
Medtronic Vascular
Neurology · 47d
Cleared May 25, 1988
OCHSNER & MICRON FABRIC PATCH
K881508 · DXZ
Intervascular, Inc.
Cardiovascular · 44d
Cleared May 25, 1988
SUNGLASSES
K881594 · HQY
Transfers Intl., Inc.
Ophthalmic · 43d
Cleared May 25, 1988
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
K881712 · DTB
Medtronic Vascular
Cardiovascular · 34d
Cleared May 25, 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · IZH
General Electric Co.
Radiology · 21d
Cleared May 25, 1988
CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE
K881922 · LDZ
Surgipath Medical Industries, Inc.
Pathology · 16d
Cleared May 25, 1988
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
K881927 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 16d
Cleared May 25, 1988
ATS NAC-PAC SET
K881949 · JSK
Alpha-Tec Systems, Inc.
Microbiology · 15d
Cleared May 24, 1988
WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
K863395 · CGZ
Wescor, Inc.
Toxicology · 629d
Cleared May 24, 1988
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875100 · DTB
Intermedics, Inc.
Cardiovascular · 166d
Cleared May 24, 1988
NEZHAT IRRIGATION PUMP SYSTEM
K880763 · HET
Cabot Medical Corp.
Obstetrics & Gynecology · 89d