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
99745–99768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1995
DEGUBOND X-LITE PLUS
K955118 · EJT
Degussa Corp.
Dental · 32d
Cleared Dec 11, 1995
CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT
K955154 · JIX
Alko Diagnostic Corp.
Chemistry · 28d
Cleared Dec 11, 1995
NT SERIES DIGITAL IMAGE MANAGER
K955232 · LMB
Camtronics, Ltd.
Radiology · 27d
Cleared Dec 11, 1995
DAR-2400-15B/30B
K955395 · IZI
Shimadzu Medical Systems
Radiology · 17d
Cleared Dec 11, 1995
PROSTYLE INTRA
K955429 · EHD
Planmeca Oy
Radiology · 13d
Cleared Dec 11, 1995
ACETAL DENTAL/PREFORMED CLASP
K955946 · EHP
Pressing DI Monticelli Rag. Stefano
Dental · 45d
Cleared Dec 08, 1995
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622 · MKZ
Abbott Laboratories
Microbiology · 802d
Cleared Dec 08, 1995
ALRECO 40400
K951926 · BTI
Allan Rehnstrom AB
Anesthesiology · 227d
Cleared Dec 08, 1995
INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER
K952237 · MBI
Innovasive Devices, Inc.
Orthopedic · 210d
Cleared Dec 08, 1995
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · MGQ
Sherwood Medical Co.
General & Plastic Surgery · 165d
Cleared Dec 08, 1995
E-Z BREATHERS
K953042 · LWF
E-Z Kare Good Health Systems, Inc.
Ear, Nose, Throat · 176d
Cleared Dec 08, 1995
SPECULITE
K953364 · HET
Trylon Corp.
Obstetrics & Gynecology · 144d
Cleared Dec 08, 1995
MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP
K953516 · IRP
Yoav Gershoni
Physical Medicine · 135d
Cleared Dec 08, 1995
COAGULATING CANNULA DEVICE
K953696 · GEI
Dorsal Orthopedic Corp.
General & Plastic Surgery · 122d
Cleared Dec 08, 1995
OLYMPIC WARM-BASSINET
K954216 · FOH
Olympic Medical Corp.
General Hospital · 93d
Cleared Dec 08, 1995
VIDEO ENHANCEMENT UNIT
K954222 · LLZ
Perkins Mfg. Co.
Radiology · 88d
Cleared Dec 08, 1995
CIRCUIT TREE PHACO HANDPIECE
K954237 · HQC
Circuit Tree
Ophthalmic · 88d
Cleared Dec 08, 1995
SURGIN GENISIS HANDPIECE
K954238 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 88d
Cleared Dec 08, 1995
U.S. IOL PHACO HANDPIECE
K954239 · HQC
U.S. Iol, Inc.
Ophthalmic · 88d
Cleared Dec 08, 1995
SUPER SCREW 3.5 MM
K954330 · HWC
Osteomed Corp.
Orthopedic · 84d
Cleared Dec 08, 1995
MUSTANG
K954376 · IOR
Temco, Inc.
Physical Medicine · 80d
Cleared Dec 08, 1995
SURGIMOTOR
K954470 · GEY
W.O.M. World of Medicine GmbH
General & Plastic Surgery · 73d
Cleared Dec 08, 1995
GO UNIVERSALK-WIRE FLUTED DRILL
K954543 · HTY
Genesis Orthopedics, Inc.
Orthopedic · 71d
Cleared Dec 08, 1995
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
K954579 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 67d