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
93697–93720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1997
SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM
K962882 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 274d
Cleared Apr 24, 1997
IMMULITE TOXOPLASMA QUANTITATIVE IGG
K962936 · LGD
Diagnostic Products Corp.
Microbiology · 269d
Cleared Apr 24, 1997
EVS
K963886 · DYB
Applied Medical Resources
Cardiovascular · 210d
Cleared Apr 24, 1997
P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
K963989 · ITX
Cardiovascular Dynamics, Inc.
Radiology · 202d
Cleared Apr 24, 1997
FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS
K963991 · GEX
Full Spectrum, Inc.
General & Plastic Surgery · 202d
Cleared Apr 24, 1997
(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI...
K963996 · GEX
Full Spectrum, Inc.
General & Plastic Surgery · 202d
Cleared Apr 24, 1997
VANTAGE PERIPHERAL DILATATION CATHETER
K965183 · LIT
Guidant Corp.
Cardiovascular · 121d
Cleared Apr 24, 1997
CLINICAL DIAGNOSTIC SOFTWARE
K970288 · KPS
Nuccardiac Software, Inc.
Radiology · 90d
Cleared Apr 24, 1997
ACCESSORIES TO THE STEREOTACTIC BODY FRAM
K970291 · IYE
Elekta Instrument AB
Radiology · 90d
Cleared Apr 24, 1997
JUPITER PTA CATHETERS (VARIOUS)
K970299 · LIT
Cordis Corp.
Cardiovascular · 87d
Cleared Apr 24, 1997
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
K970392 · DRE
Cordis Corp.
Cardiovascular · 80d
Cleared Apr 24, 1997
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
K970519 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared Apr 24, 1997
ACUPUNCTURE NEEDLES
K970574 · MQX
C.A.I. Industries Corp.
General Hospital · 70d
Cleared Apr 24, 1997
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · JDI
Osteonics Corp.
Orthopedic · 58d
Cleared Apr 24, 1997
PYR SWAB
K970832 · JTO
Remel, Inc.
Microbiology · 48d
Cleared Apr 24, 1997
COPALIS TORC TOTAL ANTIBODY ASSAY
K970931 · LQN
Sienna Biotech, Inc.
Microbiology · 48d
Cleared Apr 23, 1997
SERVOTRONIC EC100 SYSTEM
K962087 · HWE
Medicon, Inc.
Orthopedic · 330d
Cleared Apr 23, 1997
EZ-CIRC
K963223 · HFW
Phyllis Adams, Rn, Npc, Msn
Obstetrics & Gynecology · 250d
Cleared Apr 23, 1997
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K964152 · DGC
Pharmacia, Inc.
Immunology · 189d
Cleared Apr 23, 1997
CALL-RAD PC TELERADIOLOGY
K964288 · LMA
Pc Teleradiology
Radiology · 177d
Cleared Apr 23, 1997
THERMAL REGULATION SYSTEM BLANKET
K964377 · DWJ
Gibeck, Inc.
Cardiovascular · 173d
Cleared Apr 23, 1997
CHASE RETROGRADE CARDIOPLEGIA CANNULA
K964393 · DWF
Chase Medical, Inc.
Cardiovascular · 170d
Cleared Apr 23, 1997
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
K964756 · JFH
Wano-Tech Corp.
Chemistry · 147d
Cleared Apr 23, 1997
E-Z SPACER MASK (SMALL)
K964956 · CCQ
Airpharma, LLC
Anesthesiology · 133d