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
69841–69864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2003
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K033245 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Nov 06, 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · MNI
Medtronic Sofamor Danek
Orthopedic · 27d
Cleared Nov 06, 2003
LIFEPAK 12, 20, 500, CR PLUS
K033275 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 27d
Cleared Nov 06, 2003
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
K033325 · FRN
Sorenson Medical, Inc.
General Hospital · 21d
Cleared Nov 06, 2003
APEXPRO FH TELEMETRY SYSTEM
K033365 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Nov 06, 2003
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K033374 · OEB
Siemens AG Medical Solutions
Radiology · 15d
Cleared Nov 06, 2003
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
K033425 · FRN
Sorenson Medical, Inc.
General Hospital · 10d
Cleared Nov 05, 2003
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
K031073 · LYC
Novabone Products, LLC
Dental · 215d
Cleared Nov 05, 2003
VITOSS-FILLED CARTRIDGE
K032130 · MQV
Orthovita, Inc.
Orthopedic · 117d
Cleared Nov 05, 2003
INVISIJECT RESUSABLE AUTO-INJECTOR
K032425 · KZH
Biogen
General Hospital · 91d
Cleared Nov 05, 2003
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K032439 · MKJ
Zoll Medical Corp
Cardiovascular · 90d
Cleared Nov 05, 2003
MULTILINK
K032470 · EMA
Ivoclar Vivadent, Inc.
Dental · 86d
Cleared Nov 05, 2003
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
K033034 · LPH
Zimmer, Inc.
Orthopedic · 37d
Cleared Nov 05, 2003
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · JDS
Synthes (Usa)
Orthopedic · 37d
Cleared Nov 05, 2003
ECHOCONNEX COMMUNICATOR
K033093 · LLZ
Connexmd
Radiology · 37d
Cleared Nov 05, 2003
MEDIC COLON MODEL, RELEASE 1
K033102 · JAK
Medicsight
Radiology · 37d
Cleared Nov 05, 2003
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347,...
K033112 · KTT
Hand Biomechanics Lab, Inc.
Orthopedic · 36d
Cleared Nov 05, 2003
HOFFMANN II PELVIC CLAMP
K033145 · LXT
Howmedica Osteonics Corp.
Orthopedic · 36d
Cleared Nov 05, 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · KTT
Synthes (Usa)
Orthopedic · 36d
Cleared Nov 05, 2003
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 05, 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · HWC
Biomet, Inc.
Orthopedic · 30d
Cleared Nov 05, 2003
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K033247 · DXT
Medrad, Inc.
Cardiovascular · 29d
Cleared Nov 05, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
K033300 · DDR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 22d
Cleared Nov 05, 2003
SELECTIVA SB GUIDEWIRE
K033321 · DQX
Neometrics, Inc.
Cardiovascular · 21d