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
127753–127776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1990
EQUIP COVERS, STERILE
K897120 · KKX
Amedic USA
General Hospital · 9d
Cleared Jan 03, 1990
ELT OR ERGONOMIC LIFT TRAINER
K890500 · HCC
Physical Health Devices, Inc.
Neurology · 336d
Cleared Jan 03, 1990
PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
K893622 · CBK
Preemicare Corp.
Anesthesiology · 237d
Cleared Jan 03, 1990
SILASTIC SOFT SHEETING
K894226 · FRO
Dow Corning Wright
General & Plastic Surgery · 198d
Cleared Jan 03, 1990
RENNER-PLAN
K894722 · IYE
W.D. Renner Consulting Co.
Radiology · 162d
Cleared Jan 03, 1990
ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
K895417 · LFJ
Arrow Intl., Inc.
Gastroenterology & Urology · 124d
Cleared Jan 03, 1990
GYN-PROBE
K895774 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 99d
Cleared Jan 03, 1990
OPTILASE YAG MODEL 1000
K895874 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 91d
Cleared Jan 03, 1990
MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
K896019 · GAA
Dlp, Inc.
General & Plastic Surgery · 79d
Cleared Jan 03, 1990
MEDISONIC PNEU-NEB
K896192 · CAF
Medisonic U.S.A., Inc.
Anesthesiology · 70d
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