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
104593–104616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1995
CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET
K941190 · FPA
Icu Medical, Inc.
General Hospital · 323d
Cleared Jan 31, 1995
DRIED GRAM NEGATIVE/CEFMETAZOLE
K941317 · JWY
Baxter Diagnostics, Inc.
Microbiology · 319d
Cleared Jan 31, 1995
NEUROLINK EEG/EP/EMG SURFACE ELECTRODES
K942921 · GXY
Neuro Supplies, Inc.
Neurology · 224d
Cleared Jan 31, 1995
ALL SILICONE INTERMITTENT CATHETER
K943851 · GBM
Rochester Medical Corp.
Gastroenterology & Urology · 176d
Cleared Jan 31, 1995
BNOS MICROVENT, MODEL AC AND MODEL AO
K944397 · BTL
Racal Health & Safety, Inc.
Anesthesiology · 145d
Cleared Jan 31, 1995
SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP...
K944680 · FMI
Researched, Novel Medical Devices...
General Hospital · 131d
Cleared Jan 31, 1995
TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER
K945382 · HLQ
Expertech Assoc., Inc.
Ophthalmic · 90d
Cleared Jan 31, 1995
VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300
K945385 · MHX
Pace Tech, Inc.
Cardiovascular · 89d
Cleared Jan 31, 1995
DURALASTIC SHEETING
K945552 · MIB
Applied Biomaterial Technologies
General & Plastic Surgery · 82d
Cleared Jan 31, 1995
SK S-RAY GRIDS
K945697 · IXJ
Seibu Techno Coproration
Radiology · 75d
Cleared Jan 31, 1995
BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS
K945995 · GEI
Ximed/Prosure/Injectx
General & Plastic Surgery · 117d
Cleared Jan 31, 1995
FI, GORDY TOY, WELLJOY AND OTHERS
K946004 · HQY
Fundamental Industrial Co., Ltd.
Ophthalmic · 53d
Cleared Jan 31, 1995
AVON SUNNY DAYS SUNGLASSES
K946091 · HQY
Siegel,Mandell & Davidson,P.C.
Ophthalmic · 48d
Cleared Jan 31, 1995
AVON SUNNY DAYS SUNGLASSES
K946092 · HQY
Siegel,Mandell & Davidson,P.C.
Ophthalmic · 48d
Cleared Jan 31, 1995
URETHRAL SUTURE GUIDE
K950267 · KOA
Applied Medical Resources
Gastroenterology & Urology · 8d
Cleared Jan 30, 1995
OVAMED HSG CATHETER
K931122 · LKF
Ovamed Corp.
Obstetrics & Gynecology · 697d
Cleared Jan 30, 1995
NEXT GENERATION KNEE SYSTEM
K933785 · JWH
Zimmer, Inc.
Orthopedic · 544d
Cleared Jan 30, 1995
OGDEN ANCHOR ADDITIONAL APPLICATIONS
K935065 · JDR
American Medical Electronics, Inc.
Orthopedic · 467d
Cleared Jan 30, 1995
CONDOM
K940045 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 390d
Cleared Jan 30, 1995
NON-LUBRICATED CONDOM
K940046 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 390d
Cleared Jan 30, 1995
MASSAGING HELMET C.F. HANSEN DESIGN
K940582 · IRO
Philco Ushuaia
Physical Medicine · 356d
Cleared Jan 30, 1995
OSTEONICS(R) SERIES 7000 TOTAL KNEE
K940813 · JWH
Osteonics Corp.
Orthopedic · 342d
Cleared Jan 30, 1995
SINGLE HANDED BREAST PUMP
K941112 · HGX
Macneil Baby Care , Ltd.
Obstetrics & Gynecology · 329d
Cleared Jan 30, 1995
PRISM MEDICAL CUSTOM DIALYSIS KIT
K941803 · KOC
Medical Device Support Services
Gastroenterology & Urology · 293d