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
120169–120192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1991
CERAPALL 6
K911669 · EJS
Metalor Dental USA Corp.
Dental · 127d
Cleared Aug 16, 1991
CERAPLUS
K911674 · EJS
Metalor Dental USA Corp.
Dental · 127d
Cleared Aug 16, 1991
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST
K911692 · CHH
Enzymatics C/O Burditt,Bowles,Radzius...
Chemistry · 122d
Cleared Aug 16, 1991
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
K911728 · MEH
Osteonics Corp.
Orthopedic · 121d
Cleared Aug 16, 1991
H.I.STANDARD CALIBRE UPGRADE
K911746 · LNH
Health Images, Inc.
Radiology · 120d
Cleared Aug 16, 1991
TRACHEOSTOMY TUBE AND CUFF
K912124 · BTO
Concord/Portex
Anesthesiology · 95d
Cleared Aug 16, 1991
PACKS-4 (TM) ANALYZER
K912201 · JBY
Helena Laboratories
Hematology · 88d
Cleared Aug 16, 1991
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO
K912205 · HRX
Microaire
Orthopedic · 88d
Cleared Aug 16, 1991
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO.
K912206 · HRX
Microaire
Orthopedic · 88d
Cleared Aug 16, 1991
ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS
K912337 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 84d
Cleared Aug 16, 1991
OLYMOUS XLS XENON LIGHT SOURCE
K912354 · GCT
Perkinelmer Optoelectronics
Gastroenterology & Urology · 80d
Cleared Aug 16, 1991
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
K912365 · JXN
Abbott Laboratories
Toxicology · 79d
Cleared Aug 16, 1991
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K912415 · BZQ
Medtronic Vascular
Anesthesiology · 77d
Cleared Aug 16, 1991
CANDELA INTRODUCER SHEATH SYSTEM
K912443 · FDE
Candela Laser Corp.
Gastroenterology & Urology · 74d
Cleared Aug 16, 1991
CITATION MEDICAL SCOPE PROCEDURE PACK
K912490 · KKX
Citation Medical Corp.
General Hospital · 73d
Cleared Aug 16, 1991
JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION
K912537 · BXB
Thera Kinetics, Inc.
Physical Medicine · 67d
Cleared Aug 16, 1991
1.1, 1.2, 1.3 TEMPERATURE PROBES
K912650 · FLL
Vital Signs, Inc.
General Hospital · 60d
Cleared Aug 16, 1991
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
K912654 · MEH
Osteonics Corp.
Orthopedic · 60d
Cleared Aug 16, 1991
HIGH DENSITY LIPOPROTEIN CHOLESTEROL
K912823 · LBR
Creative Laboratory Products, Inc.
Chemistry · 51d
Cleared Aug 16, 1991
PERCUTANEOUS RETRACTOR KIT
K912903 · GCJ
Applied Urology, Inc.
General & Plastic Surgery · 45d
Cleared Aug 16, 1991
PLANUSTAR AND DENS NOBILIS DENTURE TEETH
K912989 · EMI
Wilde-USA, Inc.
Dental · 39d
Cleared Aug 16, 1991
OPTI-PLAST 5F PTA CATHETERS
K913112 · LIT
Vas-Cath, Inc.
Cardiovascular · 42d
Cleared Aug 16, 1991
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
K913120 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 32d
Cleared Aug 16, 1991
OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400
K913121 · KXJ
Continental X-Ray Corp.
Radiology · 31d