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
107857–107880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1994
PASCO MIC AND MIC/ID PANELS
K935805 · JTT
Pasco Laboratories, Inc.
Microbiology · 193d
Cleared Jun 13, 1994
ELECTROSURGICAL PENCIL
K936304 · GEI
E & M Engineering, Inc.
General & Plastic Surgery · 175d
Cleared Jun 13, 1994
GLUCOMETER ELITE LOW CONTROL
K940577 · JJX
Heraeus Kulzer, Inc.
Chemistry · 125d
Cleared Jun 13, 1994
SKYTRON ELITE 3500 TABLE
K940616 · GDC
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 119d
Cleared Jun 13, 1994
ACU-SIZER(TM)
K941011 · EYB
Applied Medical Resources
Gastroenterology & Urology · 102d
Cleared Jun 13, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
K941142 · DIP
Eastman Kodak Company
Chemistry · 95d
Cleared Jun 13, 1994
DYE MANAGEMENT SYSTEM
K941254 · DQO
Abbott Laboratories
Cardiovascular · 94d
Cleared Jun 13, 1994
CEDIA DIGOXIN PLUS ASSAY
K941255 · KXT
Microgenics Corp.
Toxicology · 91d
Cleared Jun 13, 1994
ACE SPORTS TAPE
K941379 · KGX
Becton Dickinson Consumer Products
General & Plastic Surgery · 83d
Cleared Jun 13, 1994
ASCENDA
K941642 · ING
American Stair-Glide Corp.
Physical Medicine · 70d
Cleared Jun 13, 1994
COBAS-FP REAGENTS AND CALIBRATORS
K941712 · LGJ
Roche Diagnostic Systems, Inc.
Toxicology · 68d
Cleared Jun 13, 1994
WHEELCHAIR,MECHANICAL
K941976 · IOR
Tone World International
Physical Medicine · 52d
Cleared Jun 13, 1994
EPI-DERM SILICONE GEL SHEETING
K942156 · MDA
Biodermis Corp.
General & Plastic Surgery · 41d
Cleared Jun 13, 1994
MICROFLEX
K942304 · FSO
Moeller Microsurgical, Inc.
General & Plastic Surgery · 31d
Cleared Jun 13, 1994
R-BAR RETRACTOR
K942415 · GCJ
Linvatec Corp.
General & Plastic Surgery · 24d
Cleared Jun 10, 1994
GORE-TEX REGENERATIVE MATERIAL
K922627 · NPK
W.L. Gore & Associates, Inc.
Dental · 737d
Cleared Jun 10, 1994
OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES
K926596 · HET
Owens Industries, Inc.
Obstetrics & Gynecology · 639d
Cleared Jun 10, 1994
STERILE SURGEON'S GOWN, MODIFICATION
K931144 · FYA
Amsco Sterile Recoveries, Inc.
General Hospital · 462d
Cleared Jun 10, 1994
NON-STERILE ISOLATION GOWN
K931145 · FYC
Amsco Sterile Recoveries, Inc.
General Hospital · 462d
Cleared Jun 10, 1994
RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE
K931874 · FRG
Amsco Sterile Recoveries, Inc.
General Hospital · 422d
Cleared Jun 10, 1994
AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE
K931875 · FRG
Amsco Sterile Recoveries, Inc.
General Hospital · 422d
Cleared Jun 10, 1994
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
K932477 · KPE
Baxter Healthcare Corp
General Hospital · 382d
Cleared Jun 10, 1994
MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF
K933750 · GCJ
Microsurge, Inc.
General & Plastic Surgery · 330d
Cleared Jun 10, 1994
PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
K933960 · CAC
Cobe Cardiovascular, Inc.
Anesthesiology · 298d