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
128353–128376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1990
OPTEX BLOOD GAS MONITORING SYSTEM
K896311 · CCE
Optex Biomedical
Anesthesiology · 63d
Cleared Jan 03, 1990
AMSCO QUANTUM LIGHT
K896674 · FSY
American Sterilizer Co.
General & Plastic Surgery · 37d
Cleared Jan 03, 1990
B.A.C. 3000 CHAIR/STANDER
K896904 · IPL
Luconex, Inc.
Physical Medicine · 26d
Cleared Jan 03, 1990
SUNBRONZE SB24C/65 ULTRA
K896983 · LEJ
Sunbronze
General & Plastic Surgery · 20d
Cleared Jan 02, 1990
PATIENT EXAMINATION GLOVES
K892779 · LYY
Jamuri Sdn. Bhd.
General Hospital · 266d
Cleared Jan 02, 1990
DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER
K893254 · KHX
Dalphi, Inc.
Physical Medicine · 249d
Cleared Jan 02, 1990
PATIENT EXAMINATION GLOVES
K894121 · LYY
Pro-Tex Products, Inc.
General Hospital · 204d
Cleared Jan 02, 1990
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
K895505 · LJC
Eastman Kodak Company
Microbiology · 113d
Cleared Jan 02, 1990
ANSELL DENTA GLOVES
K895660 · LYY
Ansell, Inc.
General Hospital · 104d
Cleared Jan 02, 1990
CEFMATZOLE 30 MCG SENSI DISC
K895679 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 104d
Cleared Jan 02, 1990
ELECTRICAL MUSCLE STIMULATOR--PGS 2000 TENS DEVICE
K895760 · IPF
Universal Technology Systems, Inc.
Physical Medicine · 98d
Cleared Jan 02, 1990
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE
K895797 · FRN
Imed Corp.
General Hospital · 96d
Cleared Jan 02, 1990
MEDI-PACK
K895860 · IMD
Heatmax Mfg., Inc.
Physical Medicine · 91d
Cleared Jan 02, 1990
OLYMPUS VALVULOTOME W/DETACHABLE TIP
K895878 · DWX
Olympus Corp.
Cardiovascular · 89d
Cleared Jan 02, 1990
MATRIX(TM)-96
K896202 · JJJ
Canberra Industries, Inc.
Chemistry · 68d
Cleared Jan 02, 1990
TITANIUM LIGATING CLIPS
K896262 · HBT
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 64d
Cleared Jan 02, 1990
DYONICS SHOULDER PORTAL SYSTEM
K896416 · HRX
Dyonics, Inc.
Orthopedic · 55d
Cleared Jan 02, 1990
AUTOSCEPTOR
K896447 · LRG
Bd Becton Dickinson Vacutainer...
Microbiology · 54d
Cleared Jan 02, 1990
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY
K896522 · JJY
Casco Standards
Chemistry · 48d
Cleared Jan 02, 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526 · JGS
Baxter Healthcare Corp
Chemistry · 50d
Cleared Jan 02, 1990
MEDX CERVICAL EXTENSION TEST & REHAB MACHINE
K896553 · IKK
Medx Corp.
Physical Medicine · 46d
Cleared Jan 02, 1990
MAL LATEX EXAMINATION GLOVES
K896604 · LYY
Pt. Maja Agung Latexindo
General Hospital · 42d
Cleared Jan 02, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
K896640 · CGJ
Medix Biotech, Inc.
Chemistry · 39d
Cleared Jan 02, 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692 · CEM
Baxter Healthcare Corp
Chemistry · 35d