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
135265–135288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1988
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · FPB
Miles Laboratories, Inc.
General Hospital · 104d
Cleared May 26, 1988
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
K880801 · FGB
Medical Engineering Corp.
Gastroenterology & Urology · 87d
Cleared May 26, 1988
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
K880802 · FGB
Medical Engineering Corp.
Gastroenterology & Urology · 87d
Cleared May 26, 1988
KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE
K880850 · FEG
Kmb Medical Products Co.
Gastroenterology & Urology · 86d
Cleared May 26, 1988
CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
K880860 · DQT
Dlp, Inc.
Cardiovascular · 86d
Cleared May 26, 1988
MICROLINE CAT #100
K880943 · HQE
Microline Pentax, Inc.
Ophthalmic · 80d
Cleared May 26, 1988
MSI 2002 SERIES BED
K881027 · FNL
Med Service, Inc.
General Hospital · 77d
Cleared May 26, 1988
CHECK VALVE
K881052 · FPA
Baxter Healthcare Corp
General Hospital · 76d
Cleared May 26, 1988
MEADOX INTRA-AORTIC GRAFT
K881283 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 62d
Cleared May 26, 1988
VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.
K881711 · DXY
Telectronics and Cordis Pacing Systems
Cardiovascular · 36d
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