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
139345–139368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1987
AMEDA AMELETTE(R) NEONATAL INCUBATOR
K870223 · FMZ
Hollister, Inc.
General Hospital · 140d
Cleared Jun 10, 1987
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K870945 · JTL
Oxoid U.S.A., Inc.
Microbiology · 93d
Cleared Jun 10, 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K871192 · LJT
Norfolk Medical Products, Inc.
General Hospital · 78d
Cleared Jun 10, 1987
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K871268 · HLI
G. Rodenstock Instrumente GmbH
Ophthalmic · 71d
Cleared Jun 10, 1987
SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE
K871282 · FFT
Synectics-Dantec
Gastroenterology & Urology · 71d
Cleared Jun 10, 1987
Q.I.C. BLEEDING TIME DEVICE
K871318 · JCA
Helena Laboratories
Hematology · 68d
Cleared Jun 10, 1987
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
K871610 · KNX
Coloplast A/S
Gastroenterology & Urology · 47d
Cleared Jun 10, 1987
CONVEEN(R) LEG-BAG (600 ML)
K871643 · KNX
Coloplast A/S
Gastroenterology & Urology · 44d
Cleared Jun 10, 1987
URETERAL STENT
K871667 · FAD
Penn Medical Devices, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 10, 1987
BIODAN TYPE COMET ELECTRODE
K871668 · DRX
National Medical Technology
Cardiovascular · 43d
Cleared Jun 10, 1987
THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE
K871748 · DRX
The Buddy Systems, Inc.
Cardiovascular · 36d
Cleared Jun 10, 1987
MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
K871915 · DTE
Pace Medical
Cardiovascular · 23d
Cleared Jun 10, 1987
ORICULT-N CULTURE-PADDLE
K872058 · JSI
Orion Corp.
Microbiology · 13d
Cleared Jun 09, 1987
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
K861730 · FKQ
Renal Systems, Inc.
Gastroenterology & Urology · 399d
Cleared Jun 09, 1987
MULTI-FLEX TABLE -- MODEL 101
K870710 · JFB
Slenderizers Equipment Mfg., Inc.
Physical Medicine · 109d
Cleared Jun 09, 1987
MULTI-FLEX TABLE -- MODEL 102
K870711 · JFB
Slenderizers Equipment Mfg., Inc.
Physical Medicine · 109d
Cleared Jun 09, 1987
MULTI-FLEX TABLE -- MODEL 103
K870712 · JFB
Slenderizers Equipment Mfg., Inc.
Physical Medicine · 109d
Cleared Jun 09, 1987
MULTI-FLEX TABLE -- MODEL 104
K870713 · JFB
Slenderizers Equipment Mfg., Inc.
Physical Medicine · 109d
Cleared Jun 09, 1987
MULTI-FLEX TABLE -- MODEL 105
K870714 · JFB
Slenderizers Equipment Mfg., Inc.
Physical Medicine · 109d
Cleared Jun 09, 1987
MULTI-FLEX TABLE -- MODEL 106
K870715 · JFB
Slenderizers Equipment Mfg., Inc.
Physical Medicine · 109d
Cleared Jun 09, 1987
UROSCAN
K870855 · FAP
Endotherapeutics
Gastroenterology & Urology · 98d
Cleared Jun 09, 1987
ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET
K871019 · KNT
Entech, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 09, 1987
ORTHOMET AUSTIN-MOORE SYSTEM
K871656 · KWL
Orthomet, Inc.
Orthopedic · 42d
Cleared Jun 09, 1987
LYOSHEET SURGICAL SHEET FOR BURNS
K871740 · FPY
Acme United Corp.
General & Plastic Surgery · 35d