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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167041–167064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1980
SMR H-CHAIR
K800526 · ETF
Surgical Mechanical Research, Inc.
Ear, Nose, Throat · 11d
Cleared Mar 18, 1980
SUPERSIL
K800548 · ELW
Harry J. Bosworth Co.
Dental · 8d
Cleared Mar 17, 1980
AUTOSCAN 3
K792647 · JJQ
Cnr Labs
Microbiology · 82d
Cleared Mar 17, 1980
DENTSPLY DENTURE CLEANER
K800166 · JER
Dentsply Intl.
Dental · 52d
Cleared Mar 17, 1980
RITTER MODEL H COMPANION STOOL
K800276 · KLC
Sybron Corp.
Dental · 38d
Cleared Mar 17, 1980
ARCOLITH 3021-CARDIAC PULSE GENERATOR
K800326 · DXY
Arco Medical Products Co.
Cardiovascular · 34d
Cleared Mar 17, 1980
FES ORTHOSIS MODEL NO. 2000
K800380 · GZI
Empi
Neurology · 24d
Cleared Mar 17, 1980
ARISTOSURG 250
K800395 · EIA
Halmon-Locren, Inc.
Dental · 20d
Cleared Mar 12, 1980
DMS 3000
K792252 · FKQ
Renal Care Corp.
Gastroenterology & Urology · 125d
Cleared Mar 12, 1980
SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.
K792349 · JNT
Pfizer, Inc.
Microbiology · 114d
Cleared Mar 12, 1980
SURGICOT 2 INDICATOR SYSTEM
K800029 · FRC
Surgicot, Inc.
General Hospital · 65d
Cleared Mar 12, 1980
BOND ELUT COLUMNS
K800061 · DJY
Analytichem International, Inc.
Toxicology · 63d
Cleared Mar 12, 1980
DURALITE LENS
K800192 · HPX
American Optical Corp.
Ophthalmic · 43d
Cleared Mar 12, 1980
STERILE GC SUPPLEMENT
K800252 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
MYCOPLASMA SUPPLEMENT G
K800253 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
MYCOPLASMA SUPPLEMENT P
K800254 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
STERILE GC SUPPLEMENT (W/O ANTIBIOTICS)
K800255 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
TINSDALE SUPPLEMENT
K800256 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
CAMPYLOBACTER SELECTIVE SUPPLEMENT
K800257 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT
K800258 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
OXYTETRACYCLINE ANTIBIOTIC SUPPLEMENT
K800259 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
STREPTOCOCCUS SUPPLEMENT
K800260 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
DERMASEL SUPPLEMENT
K800261 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
PERFRINGENS SUPPLEMENT A
K800262 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d