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
123241–123264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 07, 1991
CONTAIN(TM)
K895859 · GCX
Arbor Technologies, Inc.
General Hospital · 492d
Cleared Feb 07, 1991
THE WONDER BOX
K901797 · GWL
Micro Tronics Corp.
Neurology · 294d
Cleared Feb 07, 1991
ABBOTT VISION(TM) GLYCATED HB
K904027 · LCP
Abbott Laboratories
Hematology · 161d
Cleared Feb 07, 1991
BARD UTERINE MANIPULATOR
K904079 · LKF
C.R. Bard, Inc.
Obstetrics & Gynecology · 155d
Cleared Feb 07, 1991
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS
K904689 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 120d
Cleared Feb 07, 1991
WEP-8430A TELEMETRY CENTRAL STATION
K904696 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 176d
Cleared Feb 07, 1991
DIGITAL THERMOMETER KITS
K905025 · FLL
Abco Dealers, Inc.
General Hospital · 92d
Cleared Feb 07, 1991
ALTAIR
K905072 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 90d
Cleared Feb 07, 1991
FLO-RESTER(R) VESSEL SIZER
K905159 · DWP
Bio-Vascular, Inc.
Cardiovascular · 83d
Cleared Feb 07, 1991
MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A
K905251 · FRN
Medical Technical Products
General Hospital · 78d