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
106273–106296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1994
PRECISION UV(TM) (VASURFILCON A)
K944722 · LPL
Pilkington Barnes-Hind, Ltd.
Ophthalmic · 4d
Cleared Sep 30, 1994
BIOLOGIC DT-1000 MACHINE
K923046 · KNT
Hemocleanse, Inc.
Gastroenterology & Urology · 828d
Cleared Sep 30, 1994
WALLSTENT BILIARY ENDOPROTHESES
K923993 · FGE
Schneider U.S. Stent Div.
Gastroenterology & Urology · 781d
Cleared Sep 30, 1994
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS
K925274 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 711d
Cleared Sep 30, 1994
ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.
K925405 · FFT
Synectics-Dantec
Gastroenterology & Urology · 704d
Cleared Sep 30, 1994
CENTRYSYSTEM 3 WITH CHARTS/BP OPTION
K925522 · KOC
C.G.H. Medical, Inc.
Gastroenterology & Urology · 697d
Cleared Sep 30, 1994
BAXTER CT DIALYZER
K926568 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 638d
Cleared Sep 30, 1994
GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.
K933300 · KNF
Lyle Howard Corp.
Obstetrics & Gynecology · 450d
Cleared Sep 30, 1994
SURGICAL APPAREL
K935199 · KKY
Associated Hospital Services, Inc.
General Hospital · 338d
Cleared Sep 30, 1994
NO-MES
K935633 · KNT
Ethox Corp.
Gastroenterology & Urology · 311d
Cleared Sep 30, 1994
ISOCAM II (DUAL HEAD GAMMA CAMERA)
K940487 · KPS
Independent Scintilation Imaging...
Radiology · 239d
Cleared Sep 30, 1994
CLEAN-SORB
K941099 · EFQ
Hospital Specialty Co.
General & Plastic Surgery · 207d
Cleared Sep 30, 1994
ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER
K941814 · FOS
Sherwood Medical Co.
General Hospital · 171d
Cleared Sep 30, 1994
WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE
K941958 · KPO
Western Dialysis Supplies , Ltd.
Gastroenterology & Urology · 161d
Cleared Sep 30, 1994
4-LEAD IRRIGATION SET
K942101 · HRX
Douglas Medical Products Corp.
Orthopedic · 151d
Cleared Sep 30, 1994
DIGITAL I.D. CAMERA
K942883 · JAC
Miles Inc., Agfa Division
Radiology · 105d
Cleared Sep 30, 1994
ORACLE MRI WHOLE BODY MR IMAGING SYSTEM
K942953 · LNH
Otsuka Electronics USA, Inc.
Radiology · 100d
Cleared Sep 30, 1994
CVD BULLETT PERIPHERAL INFUSION CATHETER
K943023 · FOZ
Cardiovascular Dynamics, Inc.
General Hospital · 98d
Cleared Sep 30, 1994
IV TRANSFER SPIKE
K943095 · LHI
Migada, Ltd.
General Hospital · 94d
Cleared Sep 30, 1994
INTERFERENCE SCREW
K943160 · HWC
Applied Osteo Systems, Inc.
Orthopedic · 91d
Cleared Sep 30, 1994
HP 77010CF
K943634 · IYO
Hewlett-Packard Co.
Radiology · 66d
Cleared Sep 30, 1994
AQUAPLAST TIE DOWN DRESSING
K943871 · LZM
Wfr/Aquaplast Corp.
General & Plastic Surgery · 53d
Cleared Sep 30, 1994
CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER
K944090 · GEX
Candela Laser Corp.
General & Plastic Surgery · 39d
Cleared Sep 29, 1994
GORE-TEX SOFT TISSUE PATCH PLUS
K922452 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 856d