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
136081–136104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1988
AUTOMATIC PERIMETER, AP-340
K881219 · HPT
Kowa Optimed, Inc.
Ophthalmic · 42d
Cleared May 03, 1988
PORGES URETERAL STENT
K881744 · FAD
Bivona Medical Technologies
Gastroenterology & Urology · 11d
Cleared May 02, 1988
INFANT CANNULA
K873012 · DQR
Gresco International, Inc.
Cardiovascular · 272d
Cleared May 02, 1988
ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.
K874363 · IYO
Acuson Computed Sonography
Radiology · 192d
Cleared May 02, 1988
SL SERIES, SL 15, 18, 20 & 25
K874558 · IYE
Philips Medical Systems, Inc.
Radiology · 180d
Cleared May 02, 1988
10 AND 12 FRENCH VESSEL DILATORS
K874738 · DRE
Impra, Inc.
Cardiovascular · 166d
Cleared May 02, 1988
XENEX DENTAL ROULETTE
K880485 · EFW
G & A Industries, Inc.
Dental · 88d
Cleared May 02, 1988
MAMMOGRAPHIC X-RAY SYSTEM ATHENA
K880531 · IZH
Fischer Imaging Corp.
Radiology · 83d
Cleared May 02, 1988
DENTALVISION TV SYSTEM
K880542 · EKJ
Dentsply Intl.
Dental · 83d
Cleared May 02, 1988
MINOS AUTOMATIC CELL COUNTER
K880616 · GKZ
Abx, Inc.
Hematology · 76d
Cleared May 02, 1988
FIBEROPTIC CATHETER
K880661 · DQO
Optimed Technologies, Inc.
Cardiovascular · 75d
Cleared May 02, 1988
ENDOMED CV405
K880699 · IPF
Henley Intl.
Physical Medicine · 70d
Cleared May 02, 1988
7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM
K880776 · DQR
Medsurg Industries, Inc.
Cardiovascular · 66d
Cleared May 02, 1988
RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300
K880865 · BXB
Invacare Corp.
Physical Medicine · 62d
Cleared May 02, 1988
TECH-CAL(TM)/MULTIPLE
K881161 · KSA
R&D Systems, Inc.
Hematology · 45d
Cleared May 02, 1988
VERIFY(R) REFERENCE PLASMA
K881348 · GGN
Organon Teknika Corp.
Hematology · 33d
Cleared Apr 29, 1988
EXL-22DP X-RAY RADIATION THERAPY SYSTEM
K873398 · IYE
Mitsubishi Intl. Corp.
Radiology · 249d
Cleared Apr 29, 1988
ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
K874154 · KNT
Electro-Catheter Corp.
Gastroenterology & Urology · 199d
Cleared Apr 29, 1988
SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
K875266 · DPT
Toshiba Medical Systems
Cardiovascular · 129d
Cleared Apr 29, 1988
MODEL 210A INFUSION PUMP
K875347 · FRN
Avi, Inc.
General Hospital · 120d
Cleared Apr 29, 1988
MODEL 400A INFUSION PUMP
K875348 · FRN
Avi, Inc.
General Hospital · 120d
Cleared Apr 29, 1988
MODEL 200A INFUSION PUMP
K875365 · FRN
Avi, Inc.
General Hospital · 120d
Cleared Apr 29, 1988
MINI-FILTER, VIROBAC II
K880681 · CAH
King Systems Corp.
General Hospital · 70d
Cleared Apr 29, 1988
BASSINET STAND WITH DRESSING TRAY
K880838 · FMS
Serv-Queen, Inc.
General Hospital · 59d