FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
70345–70368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2003
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
K032473 · HRX
Stryker Instruments
Orthopedic · 87d
Cleared Nov 07, 2003
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND...
K032647 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 72d
Cleared Nov 07, 2003
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
K032697 · JIS
Dade Behring, Inc.
Chemistry · 66d
Cleared Nov 07, 2003
PROCLEAR COMPATIBLES MULTIFOCAL
K032873 · LPL
CooperVision, Inc.
Ophthalmic · 53d
Cleared Nov 07, 2003
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
K033061 · JIX
Diamond Diagnostics, Inc.
Chemistry · 39d
Cleared Nov 07, 2003
DGH 55 HANDHELD PACHYMETER (PACHMATE)
K033385 · IYO
Dgh Technology, Inc.
Radiology · 15d
Cleared Nov 07, 2003
3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610,...
K033430 · DZE
Implant Innovations, Inc.
Dental · 10d
Cleared Nov 06, 2003
KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K030359 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 276d
Cleared Nov 06, 2003
VITERION 100 TELEHEALTH MONITOR
K030419 · MWI
Viterion Telehealthcare, LLC
Cardiovascular · 269d
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