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
72625–72648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2003
SHARP VIEW IMAGE ENHANCEMENT SYSTEM
K024028 · LLZ
Context Vision AB
Radiology · 49d
Cleared Jan 24, 2003
IVUS PLUS
K024103 · LLZ
Indec Systems, Inc.
Radiology · 43d
Cleared Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · DQX
Guidant Corp.
Cardiovascular · 21d
Cleared Jan 24, 2003
BURBANK TENACULUM, MODEL 09-0011-01
K030078 · HDC
Vascular Control Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Jan 24, 2003
H2 HEATED HUMIDIFIER
K030090 · BTT
Respironics, Inc.
Anesthesiology · 14d
Cleared Jan 24, 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
K030102 · JJT
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 24, 2003
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
K030179 · NKX
Surgical Instruments Service and...
Ophthalmic · 7d
Cleared Jan 23, 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143 · MQP
Interpore Cross Intl.
Orthopedic · 205d
Cleared Jan 23, 2003
BARD ER URETERAL STENT WITH SUTURE
K022447 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 181d
Cleared Jan 23, 2003
DRX3000
K022602 · ITH
Axiom Usa., Inc.
Physical Medicine · 170d
Cleared Jan 23, 2003
LUMEND FRONTRUNNER CTO CATHETER
K023114 · PDU
Lumend, Inc.
Cardiovascular · 126d
Cleared Jan 23, 2003
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K023613 · IXW
Alphatek Corp.
Radiology · 87d
Cleared Jan 23, 2003
DIMISIL SCAR GEL
K023678 · MDA
Aesthetic and Reconstructive...
General & Plastic Surgery · 83d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · KWY
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jan 23, 2003
XENO III DENTAL ADHESIVE
K023776 · KLE
Dentsply Intl.
Dental · 72d
Cleared Jan 23, 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · KWP
Depuyacromed
Orthopedic · 70d
Cleared Jan 23, 2003
RAPID THERMAL EXCHANGE SYSTEM
K023934 · DWJ
Avacore Technologies, Inc.
Cardiovascular · 58d
Cleared Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · KTT
Synthes (Usa)
Orthopedic · 58d
Cleared Jan 23, 2003
OSTEO-CABLE SLEEVE
K024022 · HXN
Biomet, Inc.
Orthopedic · 49d
Cleared Jan 23, 2003
ASCENSIA GLUCOFACTS
K024234 · NBW
Bayer Corp.
Chemistry · 31d
Cleared Jan 23, 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · KWQ
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Jan 23, 2003
FREEDOM CONSTRAINED LINERS
K030047 · KWZ
Biomet, Inc.
Orthopedic · 17d
Cleared Jan 23, 2003
TRIAGE CARDIAC CONTROLS
K030089 · JJY
Biosite Incorporated
Chemistry · 13d
Cleared Jan 22, 2003
EXEL SECURETOUCH PTP SYRINGE
K011754 · MEG
Exelint Intl. Co.
General Hospital · 595d