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
142873–142896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1986
THE LUNG GYM (XLATOR AND NLATOR)
K861564 · BWF
El-Fax Company, Inc.
Anesthesiology · 104d
Cleared Aug 07, 1986
BIO-CARB D16000, D16001, AND D17000
K861646 · FJH
Societe D' Analyses...
Gastroenterology & Urology · 99d
Cleared Aug 07, 1986
KIRSCHNER PROXIMAL FEMUR TOTAL HIP SYSTEM
K861826
Kirschner Medical Corp.
Orthopedic · 87d
Cleared Aug 07, 1986
FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND
K861837 · IMG
Fischer Industries, Inc.
Physical Medicine · 86d
Cleared Aug 07, 1986
OSSEODENT DRILLING SYSTEM
K862110 · KMW
Otc/America
Dental · 65d
Cleared Aug 07, 1986
MYOLAB II, MODEL ML-200
K862236 · IKN
Motion Control, Inc.
Neurology · 57d
Cleared Aug 07, 1986
ACE MOS SAW AND THE ACE MOS SPINE SAW
K862504 · JDX
Buckman Co., Inc.
Orthopedic · 37d
Cleared Aug 07, 1986
MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM
K862505 · JEY
Walter Lorenz Surgical, Inc.
Dental · 37d
Cleared Aug 07, 1986
PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS
K862534 · JEY
Walter Lorenz Surgical, Inc.
Dental · 36d
Cleared Aug 07, 1986
I81 INITIALES
K862623 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Aug 07, 1986
BUNN MODEL 510 MEDICATION COMPRESSOR
K862628 · BTI
The John Bunn Co.
Anesthesiology · 28d
Cleared Aug 07, 1986
C.S.M. HIP
K862752
Protek, Inc.
Orthopedic · 16d
Cleared Aug 07, 1986
SILICONE SUMP DRAIN
K862767 · GBS
Sil-Med Corp.
General & Plastic Surgery · 16d
Cleared Aug 07, 1986
SPUNGUARD PLUS SURGICAL DRAPE
K862801 · KKX
Kimberly-Clark Corp.
General Hospital · 15d
Cleared Aug 07, 1986
TEC VARI-TRAC II TRACTION UNIT
K862846 · ITH
Therapeutic Equipment Corp.
Physical Medicine · 9d
Cleared Aug 07, 1986
FRANKLIN CHAIRS/MOVES, #4000 SERIES & #4100 SERIES
K862857 · INO
Franklin Corp.
Physical Medicine · 9d
Cleared Aug 07, 1986
THE TOWERED 90/90 UNIT
K862874 · HST
Lossing Orthopedic, Inc.
Neurology · 8d
Cleared Aug 07, 1986
MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358
K862931 · KNC
Global Medical Prods, Inc.
Obstetrics & Gynecology · 3d
Cleared Aug 06, 1986
S-ROM 135 POROUS COATED FEMORAL STEM COLLAR
K860207
Joint Medical Products Corp.
Orthopedic · 196d
Cleared Aug 06, 1986
CTC 30, 40, 1 LIQUID OXYGEN LITERS
K860738 · BYJ
Cryodyne Technologies, Inc.
Anesthesiology · 160d
Cleared Aug 06, 1986
GEREONICS BIOPOTENTIAL SKIN ELECTRODES
K861099 · DRX
Gereonics, Inc.
Cardiovascular · 135d
Cleared Aug 06, 1986
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · DRX
Conmedcorp
Cardiovascular · 132d
Cleared Aug 06, 1986
DENTAL COTTON ROLLS, STERILE AND NON-STERILE
K861338 · EFN
Intl. Verbandstoff-Fabrik Schaffhau
Dental · 121d
Cleared Aug 06, 1986
NEOGUARD ECG ELECTRODES
K861364 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 117d