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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103873–103896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1995
ANGIOCATH SIDEHOLDER DRAINAGE CATHETER
K950437 · GBX
Becton Dickinson Vascular Access, Inc.
General & Plastic Surgery · 40d
Cleared Mar 14, 1995
INSYTE SIDEHOLDED DRAINAGE CATHETER
K950439 · GBX
Becton Dickinson Vascular Access, Inc.
General & Plastic Surgery · 40d
Cleared Mar 14, 1995
OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
K950569 · LZU
G.W.B. Intl., Ltd.
Ophthalmic · 41d
Cleared Mar 14, 1995
MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER
K950778 · DXQ
Shanghai Medifriend Medical Products...
Cardiovascular · 21d
Cleared Mar 14, 1995
GENT-L-KARE LACERATION TRAYS
K950850 · FRG
Premium Plastics, Inc.
General Hospital · 18d
Cleared Mar 14, 1995
CARDON PHYSICAL THERAPY TABLES MODELS: R27610
K950874 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 14d
Cleared Mar 14, 1995
ASLAN KNOT PUSHER
K950924 · FDE
Aslan Medical Technologies, Ltd.
Gastroenterology & Urology · 13d
Cleared Mar 14, 1995
HILTON, BENTLY SET, SENATOR, MAYFAIR MATCH AND MONSIUR
K950938 · HQY
Rahddim, Inc.
Ophthalmic · 25d
Cleared Mar 14, 1995
CRIT-LINE HEMATOCRIT ALERT
K950942 · JPI
In-Line Diagnostics Corp.
Hematology · 27d
Cleared Mar 14, 1995
KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES...
K950953 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 12d
Cleared Mar 13, 1995
GAMBRO FH 66 D HEMOFILTER
K933883 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 580d
Cleared Mar 13, 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION
K935544 · DZE
Implant Innovations International, Inc.
Dental · 486d
Cleared Mar 13, 1995
HY-TEC AUTOMATED EIA SYSTEM
K941278 · DHB
Hycor Biomedical, Inc.
Immunology · 361d
Cleared Mar 13, 1995
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
K941427 · JMK
Teco Diagnostics
Chemistry · 354d
Cleared Mar 13, 1995
DUAL LUMEN CATHETER (DLC) TRAY
K941851 · KOC
Neostar Medical Technologies, Inc.
Gastroenterology & Urology · 333d
Cleared Mar 13, 1995
ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR
K942344 · MKJ
Zoll Medical Corp
Cardiovascular · 301d
Cleared Mar 13, 1995
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED
K942458 · JJY
Randox Laboratories, Ltd.
Chemistry · 293d
Cleared Mar 13, 1995
PICCOLO(TM)
K942782 · JJG
Abaxis, Inc.
Chemistry · 273d
Cleared Mar 13, 1995
MYCOAKT M. AVIUM CULTURE ID KIT
K943049 · JSY
Dynagen, Inc.
Microbiology · 259d
Cleared Mar 13, 1995
MYCOAKT M KANSASII CULTURE ID KIT
K943050 · JSY
Dynagen, Inc.
Microbiology · 259d
Cleared Mar 13, 1995
MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT
K943051 · JSY
Dynagen, Inc.
Microbiology · 259d
Cleared Mar 13, 1995
COAT-A-COUNT NEONATAL TSH IRMA
K943195 · JLW
Diagnostic Products Corp.
Chemistry · 251d
Cleared Mar 13, 1995
CERVICAL FUNCTION INDICATOR
K943430 · LXJ
Whiplash Analysis, Inc.
Physical Medicine · 241d
Cleared Mar 13, 1995
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K943450 · HRX
Arthrocare Corp.
Orthopedic · 238d