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
144985–145008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1986
CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA
K853471 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 189d
Cleared Feb 24, 1986
SONOLAYER SAL-55A/55AS
K853739 · IYO
Toshiba Medical Systems
Radiology · 171d
Cleared Feb 24, 1986
THE ANSWER HEARING AID
K854438 · ESD
Electone, Inc.
Ear, Nose, Throat · 111d
Cleared Feb 24, 1986
AMBI-24 PH/PRESSURE MONITOR
K854514 · FFT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 104d
Cleared Feb 24, 1986
ERMA PC-604 BLOOD CELL COUNTER
K854677 · GKL
Future Impex Corp.
Hematology · 96d
Cleared Feb 24, 1986
ERMA PC-602 PC-603 BLOOD CELL COUNTER
K854678 · GKL
Future Impex Corp.
Hematology · 81d
Cleared Feb 24, 1986
LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)
K854719 · LIO
Xsirius Scientific, Inc.
Microbiology · 94d
Cleared Feb 24, 1986
MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
K854726 · EXB
Pfizer, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 24, 1986
TRAVONEB MODEL # TONE 1
K854747 · BTI
Travomed, Inc.
Anesthesiology · 90d
Cleared Feb 24, 1986
LDS PEEP VALVE
K854822 · BYE
Life Design Systems, Inc.
Anesthesiology · 83d
Cleared Feb 24, 1986
SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM
K855116 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 63d
Cleared Feb 24, 1986
SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM
K855117 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 63d
Cleared Feb 24, 1986
S.L.T. CONTACT LASER
K855119 · LNK
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 24, 1986
ANGIOMED RENAL DILATION SET
K855140 · KOD
Angiomed U.S., Inc.
Gastroenterology & Urology · 60d
Cleared Feb 24, 1986
MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
K860202 · DXY
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Feb 24, 1986
BIOTIS CLOSTRIDIUM DIFFICILE AGAR
K860383 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MODIFIED THAYER MARTIN
K860384 · JTY
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MAC-MUG
K860385 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SF BROTH
K860386 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS KF STREPTOCOCCUS AGAR
K860388 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN
K860390 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT
K860391 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS CETRIMIDE AGAR
K860394 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS HAEMPHILLUS ISOLATION AGAR
K860395 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d