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
115825–115848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1992
NEW COBE CARDIOPLEGIA SYSTEM
K920312 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 252d
Cleared Oct 01, 1992
MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR
K921014 · MHX
Hewlett-Packard Co.
Cardiovascular · 212d
Cleared Oct 01, 1992
SURGICAL DRAPE
K921049 · KKX
Amsco Sterile Recoveries, Inc.
General Hospital · 210d
Cleared Oct 01, 1992
HAND-E-BREATH
K921339 · CAF
Jerry Mccarty
Anesthesiology · 197d
Cleared Oct 01, 1992
CYTOCARE LASER CATHETER FOR UROLOGY
K921708 · GEX
Cytocare, Inc.
General & Plastic Surgery · 174d
Cleared Oct 01, 1992
MICRO TRAK XL SYSTEM
K921747 · LJC
Syva Co.
Microbiology · 171d
Cleared Oct 01, 1992
BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
K921848 · FSQ
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 167d
Cleared Oct 01, 1992
LATEX EXAMINATION GLOVES
K922255 · LYY
Balak Rubber (Malaysia) Sdn. Bhd.
General Hospital · 153d
Cleared Oct 01, 1992
LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA
K922509 · GEI
Everest Medical Corp.
General & Plastic Surgery · 127d
Cleared Oct 01, 1992
VISUAL HCG PREGNANCY TEST
K923376 · JHI
Tech-Co, Inc.
Chemistry · 84d
Cleared Sep 30, 1992
NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION
K912508 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 482d
Cleared Sep 30, 1992
BCM-400C
K920862 · IZI
B C Medical , Ltd.
Radiology · 218d
Cleared Sep 30, 1992
910T MONTORIZED INSTRUMENT TABLE
K922242 · HRJ
R.H. Burton Co.
Ophthalmic · 140d
Cleared Sep 30, 1992
IL TEST GLUCOSE, PN 181633-80
K922532 · CGA
Instrumentation Laboratory CO
Chemistry · 125d
Cleared Sep 30, 1992
KINETIC TECHNOLOGY POCKET PRECISION ADJUSTOR
K922692 · LXM
Kinetic Technology, Inc.
Physical Medicine · 118d
Cleared Sep 30, 1992
KINETIC TECHNOOGY PRECISION ADJUSTOR MODEL SHLCP-1
K922693 · LXM
Kinetic Technology, Inc.
Physical Medicine · 118d
Cleared Sep 30, 1992
KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4
K922694 · LXM
Kinetic Technology, Inc.
Physical Medicine · 118d
Cleared Sep 30, 1992
KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5
K922695 · LXM
Kinetic Technology, Inc.
Physical Medicine · 118d
Cleared Sep 30, 1992
MEDICAL BATTERY PACKS
K922910 · HLJ
Access / God Loves You
Ophthalmic · 224d
Cleared Sep 30, 1992
3M COLOR LASER IMAGER, MODEL 979
K923222 · LMC
3M Medical Products Group
Radiology · 91d
Cleared Sep 30, 1992
GENERAL PURPOSE FLEX COIL
K923264 · LNH
General Electric Co.
Radiology · 90d
Cleared Sep 30, 1992
OPHTHALMIC VISCOINJECTOR DRIVE
K923326 · KZE
Synergetics, Inc.
General Hospital · 85d
Cleared Sep 30, 1992
VISITEC ASPIRATING SYRINGE
K923645 · FMF
Visitec Co.
General Hospital · 71d
Cleared Sep 30, 1992
TONOSHIELD TONOMETER SHIELD
K923877 · HKY
Oasis Medical, Inc.
Ophthalmic · 58d