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
101929–101952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1995
PULPDENT GLASS IONOMER CEMENTS
K952854 · DYH
Pulpdent Corp.
Dental · 23d
Cleared Jul 13, 1995
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
K936305 · JWY
Radiometer America, Inc.
Microbiology · 569d
Cleared Jul 13, 1995
CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM
K940631 · MNH
Cross Medical Products, Inc.
Orthopedic · 514d
Cleared Jul 13, 1995
BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES
K942087 · GGP
Biopool AB
Hematology · 437d
Cleared Jul 13, 1995
METALLIC RADIAL HEAD IMPLANTS
K944507 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 301d
Cleared Jul 13, 1995
PARAMETERS MONITORES
K945099 · MHX
Ivy Biomedical Systems, Inc.
Cardiovascular · 268d
Cleared Jul 13, 1995
SILON SILICONE FOAM SHEETING
K946362 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 217d
Cleared Jul 13, 1995
MED-TEC TRAY ADAPTER
K950075 · IYE
Medtec, Inc.
Radiology · 185d
Cleared Jul 13, 1995
MULTICURE(R) S GEL PAD
K950085 · KIC
Multigestion (Deutschland) GmbH
Physical Medicine · 184d
Cleared Jul 13, 1995
GLIDING NAIL
K951809 · KTT
Encore Orthopedics, Inc.
Orthopedic · 86d
Cleared Jul 13, 1995
BIOMECHANIC LOW-PROFILE CABLE SYSTEM
K951844 · JDQ
Biomechanic, Inc.
Orthopedic · 84d
Cleared Jul 13, 1995
DADE STRATUS TROPONIN-I CONTROL
K951888 · JJX
Dade Intl., Inc.
Chemistry · 80d
Cleared Jul 13, 1995
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS...
K951890 · MMI
Dade Intl., Inc.
Chemistry · 80d
Cleared Jul 13, 1995
TENTATIVELY POLARUS EX ROD
K952534 · HSB
Acu Med, Inc.
Orthopedic · 42d
Cleared Jul 13, 1995
VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM
K952672 · KPR
Bennett X-Ray Corp.
Radiology · 31d
Cleared Jul 13, 1995
OXBORO-MEDICAL CAUTERY TIP CLEANER
K952784 · HQP
Oxboro Medical Intl., Inc.
Ophthalmic · 24d
Cleared Jul 13, 1995
FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT...
K952823 · BYD
Icor AB
Anesthesiology · 23d
Cleared Jul 13, 1995
CRONEX LOW ABSORPTION CASSETTE
K952891 · IXA
The DU Pont Co.
Radiology · 20d
Cleared Jul 12, 1995
MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS
K915766 · MOT
J. L. Shepherd and Assoc.
Radiology · 1296d
Cleared Jul 12, 1995
MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS
K915767 · MOT
J. L. Shepherd and Assoc.
Radiology · 1296d
Cleared Jul 12, 1995
PELLETHANE 75D
K940039 · DXY
Medtronic Vascular
Cardiovascular · 554d
Cleared Jul 12, 1995
LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE
K942271 · FPA
Level 1 Technologies, Inc.
General Hospital · 428d
Cleared Jul 12, 1995
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI
K942647 · JJY
Scantibodies Laboratory, Inc.
Immunology · 404d
Cleared Jul 12, 1995
CAP SAFE SYSTEM
K943057 · FMI
Medical Safety Solutions
General Hospital · 407d