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
122641–122664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1991
DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
K904558 · FOZ
Davol, Inc.
General Hospital · 129d
Cleared Feb 11, 1991
VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)
K904987 · KNW
Vibronics
Gastroenterology & Urology · 96d
Cleared Feb 11, 1991
AQUA-GARD WATERPROOF WOUND PATCH
K905022 · KGX
Bellhouse Medical, Inc.
General & Plastic Surgery · 96d
Cleared Feb 11, 1991
BIOVISION ENDOCULAR PROBE
K905115 · HGF
Douglas James Donaldson Compliance...
Obstetrics & Gynecology · 90d
Cleared Feb 11, 1991
BAERVELDT GLAUCOMA IMPLANT
K905129 · KYF
Wright Medical Corp.
Ophthalmic · 89d
Cleared Feb 11, 1991
CENTAURI
K905141 · HQF
Pfizer Laser Systems
Ophthalmic · 88d
Cleared Feb 11, 1991
IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES
K905285 · GAS
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 77d
Cleared Feb 11, 1991
IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES
K905286 · GAR
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 77d
Cleared Feb 11, 1991
IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES
K905287 · GAP
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 77d
Cleared Feb 11, 1991
MAGNETOM SP/AS (ACTIVELY SHIELDED)
K905366 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Feb 11, 1991
UST-2266U-5 CW DOPPLER TRANSDUCER
K905369 · JOP
Ge Medical Systems Information...
Cardiovascular · 74d
Cleared Feb 11, 1991
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
K905378 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 73d
Cleared Feb 11, 1991
COBE CENTRYSYSTEM 3 BICART OPTION KIT
K905388 · FKP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 73d
Cleared Feb 11, 1991
HEMASTIX REAGENT STRIPS
K905396 · JIO
Heraeus Kulzer, Inc.
Chemistry · 73d
Cleared Feb 11, 1991
PVC ROUND WOUND DRAINS
K905422 · GBX
Axiom Medical, Inc.
General & Plastic Surgery · 69d
Cleared Feb 11, 1991
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
K905426 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 69d
Cleared Feb 11, 1991
STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE
K905465 · KKX
Angiosystems, Inc.
General Hospital · 68d
Cleared Feb 11, 1991
STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE
K905466 · KKX
Angiosystems, Inc.
General Hospital · 68d
Cleared Feb 11, 1991
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484 · LCJ
Mentor Corp.
General & Plastic Surgery · 67d
Cleared Feb 11, 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 66d
Cleared Feb 11, 1991
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
K905673 · GGN
Helena Laboratories
Hematology · 55d
Cleared Feb 11, 1991
PLEUR-EVAC CHEST DRAINAGE SYSTEMS
K905768 · KDQ
Deknatel, Inc.
General Hospital · 46d
Cleared Feb 11, 1991
AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER
K910192 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 26d
Cleared Feb 11, 1991
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K910199 · GZB
Medtronic Vascular
Neurology · 26d