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
137353–137376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1987
STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX)
K874718 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 21d
Cleared Dec 07, 1987
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION
K871490 · DPW
Ge Medical Systems Information...
Cardiovascular · 237d
Cleared Dec 07, 1987
BIO-MEDICUS CANNULA-TUBING
K872033 · DWF
Bio Medicus, Inc.
Cardiovascular · 194d
Cleared Dec 07, 1987
ENVIRACAIRE MODEL EV-1
K872359 · FRF
Enviracaire Corp.
General Hospital · 172d
Cleared Dec 07, 1987
BIOMA 3500
K872370 · KRC
E.B.S., Inc.
Cardiovascular · 171d
Cleared Dec 07, 1987
UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
K872715 · JDN
Roseburg SA
Orthopedic · 150d
Cleared Dec 07, 1987
ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM
K873343 · KNT
Entech, Inc.
Gastroenterology & Urology · 110d
Cleared Dec 07, 1987
FOLEY CATHETER TEMPERATURE SENSOR
K873448 · KOD
Respiratory Support Products, Inc.
Gastroenterology & Urology · 103d
Cleared Dec 07, 1987
HI-NEK TOTAL HIP
K873632 · JDI
Orthopedic Systems, Inc.
Orthopedic · 90d
Cleared Dec 07, 1987
MODIFIED DSP100 AMPLIFIER
K873640 · DQC
Intl. Acoustics, Inc.
Cardiovascular · 89d
Cleared Dec 07, 1987
PLASTER VACUUM, 115V MODEL NO. 4183-160
K873721 · LGH
Martin Medical
Orthopedic · 83d
Cleared Dec 07, 1987
CORMED III AMBULATORY INFUSION PUMP
K873847 · FRN
C.R. Bard, Inc.
General Hospital · 76d
Cleared Dec 07, 1987
AEROSOL DELIVERY SYSTEM (AERO-TECH II)
K873930 · CAF
Cadema Medical Products, Inc.
Radiology · 73d
Cleared Dec 07, 1987
NEW C-D SYSTEM FOR SPINAL SURGERY
K873977 · JDN
Sofamor Co.
Orthopedic · 69d
Cleared Dec 07, 1987
H.T.U. (HYPERBARIC THERAPY UNIT)
K874107 · CBF
Hyox Systems C/O Mechidyne Systems, Inc.
Anesthesiology · 59d
Cleared Dec 07, 1987
TITANIUM BONE SCREWS
K874130 · HWC
Orthopedic Systems, Inc.
Orthopedic · 55d
Cleared Dec 07, 1987
GUIDE WIRE
K874164 · EZB
Endovations
Gastroenterology & Urology · 55d
Cleared Dec 07, 1987
MEDTRONIC PERMANENT LEAD INTRODUCER
K874167 · DTB
Medtronic Vascular
Cardiovascular · 55d
Cleared Dec 07, 1987
MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY
K874238 · EHD
Belmont Equipment Corp.
Radiology · 53d
Cleared Dec 07, 1987
JEHLE CORONARY PERFUSION CATHETERS
K874242 · KRA
Pilling Co.
Cardiovascular · 52d
Cleared Dec 07, 1987
TRICHOMONAS DIRECT ENZYME IMMUNOASSAY
K874259 · JWZ
California Integrated Diagnostics, Inc.
Microbiology · 48d
Cleared Dec 07, 1987
URETHAL CATHETER
K874309 · KNX
Medovations, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 07, 1987
WILSON-COOK BIOPSY FORCEPS
K874314 · KNW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 07, 1987
ENTERAL FEEDING TUBE
K874393 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 40d