FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130465–130488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1989
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · LIO
Diagnostic Products Corp.
Microbiology · 65d
Cleared Aug 03, 1989
VENTIPRESS 24 AND 14 PRESSURE VENTILATOR
K893950 · IRP
Ventipress OY
Physical Medicine · 63d
Cleared Aug 03, 1989
ABBOTT IMX(TM) D-DIMER
K893961 · GHH
Abbott Laboratories
Hematology · 63d
Cleared Aug 03, 1989
AMERLEX-MAB FT4 KIT
K894091 · CEC
Amersham Corp.
Chemistry · 55d
Cleared Aug 03, 1989
QUALICHECK 2
K894110 · JJS
Radiometer America, Inc.
Chemistry · 52d
Cleared Aug 03, 1989
OPUS IMMUNOASSAY SYSTEM
K894159 · KHO
Pb Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Aug 03, 1989
ASC-950 ECG AMPLIFIER
K894161 · DRR
Astro-Med, Inc.
Cardiovascular · 50d
Cleared Aug 03, 1989
SENSOCOR TM R-TEST 24OXL
K894234 · DXG
Sensocor
Cardiovascular · 44d
Cleared Aug 03, 1989
UNIVERSAL CEMENTED CUP
K894249 · JDI
Orthopedic Systems, Inc.
Orthopedic · 43d
Cleared Aug 03, 1989
MICRO-AIRE STERNUM SAW 4800
K894301 · KFK
Micro Surgical Instruments Corp.
General & Plastic Surgery · 41d
Cleared Aug 03, 1989
EMIT D.A.U. LOW & MEDIUM CALIBRATOR A
K894327 · DKG
Syva Co.
Toxicology · 20d
Cleared Aug 03, 1989
D88VS WHEELCHAIR POWER SYSTEM
K894346 · ITI
Damaco
Physical Medicine · 20d
Cleared Aug 03, 1989
TUFFCARE MEDICAL PRODUCTS WHEELCHAIR
K894422 · IOR
Tuffman Industries
Physical Medicine · 17d
Cleared Aug 03, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
K894425 · GGC
Analytical Control Systems, Inc.
Hematology · 17d
Cleared Aug 03, 1989
VAX-T PELVIC TRACTION BELT
K894435 · ITH
Vat-Tech, Inc.
Physical Medicine · 14d
Cleared Aug 02, 1989
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
K891013 · CCC
Medtronic Vascular
Anesthesiology · 155d
Cleared Aug 02, 1989
CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR
K891076 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 155d
Cleared Aug 02, 1989
BMS-2000 MOBILE EEG SYSTEM
K891405 · GYE
Buckman Co., Inc.
Neurology · 141d
Cleared Aug 02, 1989
BREATHING CIRCUIT BACTERIAL FILTERS
K892520 · CAH
Arbo Medical, Inc.
General Hospital · 113d
Cleared Aug 02, 1989
CANDELA UPC LASER PHOTOCOAGULATOR
K893630 · HQF
Candela Laser Corp.
Ophthalmic · 83d
Cleared Aug 02, 1989
SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
K893640 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Aug 02, 1989
QRSYSTEMS H.D. NUCLEAR IMAGING TABLE
K893826 · IYZ
Qrsystems, Inc.
Radiology · 70d
Cleared Aug 02, 1989
CYSTO APRONS IN VARIOUS SIZES
K893842 · LYU
Bemiss Jason Corp.
General Hospital · 70d
Cleared Aug 02, 1989
SERATEST ENA [SCL-70] KIT
K894411 · LKJ
Hemagen Diagnostics, Inc.
Immunology · 16d