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
144889–144912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M240)
K860657 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M250)
K860658 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d
Cleared Mar 03, 1986
MDI QUIK TEST NARCOTICS DRUG SCREEN
K853140 · DNK
Medical Diagnostics, Ca.
Toxicology · 217d
Cleared Mar 03, 1986
AOT EXTERNAL COMPRESS DEVICE
K854241 · HWN
Advanced Ortho-Technology, Inc.
Orthopedic · 133d
Cleared Mar 03, 1986
LM2000A SURGICAL SUCTION MONITOR
K854359 · KDQ
Engineering, Inc.
General Hospital · 125d
Cleared Mar 03, 1986
ADHESIVE TAPE, WOUND CARE, WOUND DRESSING
K854463 · FRO
Avery Intl.
General & Plastic Surgery · 117d
Cleared Mar 03, 1986
IV SECUREMENT DEVICES
K854464 · FRO
Avery Intl.
General & Plastic Surgery · 117d
Cleared Mar 03, 1986
DETECTACULT
K854619 · KHE
Immunostics Co., Inc.
Microbiology · 105d
Cleared Mar 03, 1986
HEPANORM CALIBRATION PLASMA SET
K854762 · KFF
American Bioproducts Co.
Hematology · 96d
Cleared Mar 03, 1986
ACUSON L538 TRANSDUCER
K854787 · ITX
Acuson Computed Sonography
Radiology · 94d
Cleared Mar 03, 1986
IMZ INTRAMOBILE CYLINDER IMPLANT
K855032 · DZE
Interpore Intl.
Dental · 77d
Cleared Mar 03, 1986
V-TREND KIT STAPH LATEX TEST
K855220 · JWX
Texas Immunology, Inc.
Microbiology · 63d
Cleared Mar 03, 1986
QUADRA-TITER I.D.
K860208 · JSS
Microtech Medical Systems, Inc.
Microbiology · 40d
Cleared Mar 03, 1986
HEMOGLOBIN REAGENT SET
K860475 · KHG
Sterling Diagnostics, Inc.
Hematology · 24d
Cleared Mar 03, 1986
SPIROMETER, MODEL TS-1000, PART NO. SLZ7504
K860522 · BZG
Teledyne Avionics Div. of Teledyne
Anesthesiology · 20d
Cleared Mar 03, 1986
CEFOTETAN 30 MCG SENSITIVITY DISCS
K860527 · JTN
Difco Laboratories, Inc.
Microbiology · 20d
Cleared Mar 03, 1986
CEFOTETAN 30 MCG SENSI DISC
K860536 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared Mar 03, 1986
POLYPET
K860617 · JTC
Instrumed, Inc.
Microbiology · 12d
Cleared Mar 03, 1986
CELLGRO HEPES BUFFER SOLUTION
K860623 · KIT
Mediatech, Inc.
Pathology · 12d
Cleared Mar 03, 1986
ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL
K860672 · KRI
American Bentley
Cardiovascular · 7d
Cleared Feb 28, 1986
SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM
K853178 · HCB
Oxford Medilog, Inc.
Neurology · 213d
Cleared Feb 28, 1986
MOLDTEC STIMULATOR
K853757 · DRT
Moldtec, Inc.
Cardiovascular · 172d
Cleared Feb 28, 1986
DOBE (MODIFIED)
K853993 · DRX
Phoenix Medical Technology, Inc.
Cardiovascular · 154d
Cleared Feb 28, 1986
TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE
K854013 · DXH
Medrand, Inc.
Cardiovascular · 151d