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
69697–69720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2003
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
K032907 · LYZ
Shijiazhuang Fuguan Plastic Products...
General Hospital · 64d
Cleared Nov 20, 2003
FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K032908 · LYZ
Shijiazhuang Fuguan Plastic Products...
General Hospital · 64d
Cleared Nov 20, 2003
EPI-SCAN, MODEL P 100
K032935 · GZO
Edx Epi-Scan, Inc.
Neurology · 59d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150...
K032938 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 59d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50...
K032940 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 59d
Cleared Nov 20, 2003
SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
K032995 · ELC
Micron Corp.
Dental · 56d
Cleared Nov 20, 2003
TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
K033035 · ILY
Tlc Marketing, Inc.
Physical Medicine · 52d
Cleared Nov 20, 2003
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
K033057 · FYA
Deroyal
General Hospital · 52d
Cleared Nov 20, 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
K033237 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 45d
Cleared Nov 20, 2003
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
K033401 · BWF
Advanced Circulatory Systems, Inc.
Anesthesiology · 27d
Cleared Nov 20, 2003
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
K033431 · KPS
Cti Pet Systems, Inc.
Radiology · 23d
Cleared Nov 20, 2003
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
K033438 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 23d
Cleared Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K033501 · JIX
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502 · JAK
Ge Medical Systems, LLC
Radiology · 15d
Cleared Nov 20, 2003
REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
K033593 · NLU
Clearmedical, Inc.
Gastroenterology & Urology · 7d
Cleared Nov 19, 2003
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
K032802 · QPB
Hk Surgical, Inc.
General & Plastic Surgery · 71d
Cleared Nov 19, 2003
COOK CODA BALLOON CATHETER
K032869 · DQY
Cook, Inc.
Cardiovascular · 65d
Cleared Nov 19, 2003
INTERLAB IMMUNOFIXATION TEST(S)
K033187 · CFF
Interlab S.R.L.
Immunology · 49d
Cleared Nov 19, 2003
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
K033188 · MMX
Idev Technologies, Inc.
Cardiovascular · 49d
Cleared Nov 19, 2003
SCOUT PRO
K033320 · DQY
Biotronik, Inc.
Cardiovascular · 35d
Cleared Nov 19, 2003
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
K033345 · KPR
Analogic Corp.
Radiology · 30d
Cleared Nov 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · JDK
Implex Corp.
Orthopedic · 27d
Cleared Nov 19, 2003
SPEEDLYSER INFUSION CATHETER KIT
K033443 · QEY
AngioDynamics, Inc.
Cardiovascular · 21d
Cleared Nov 19, 2003
GE PRECISION MPI
K033486 · OWB
Nrt-Nordisk Rontgen Teknik A/S
Radiology · 15d