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
103561–103584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1995
ATTENUATION CORRECTION
K945652 · KPS
GE Medical Systems
Radiology · 134d
Cleared Mar 31, 1995
PREFERENCE MAMMOGRAPHY SYSTEM
K945743 · IZH
Philips Medical Systems (Cleveland),...
Radiology · 128d
Cleared Mar 31, 1995
SIMVIEW(TM) 3000
K946053 · KPQ
Siemens Medical Solutions USA, Inc.
Radiology · 109d
Cleared Mar 31, 1995
SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE
K946240 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 99d
Cleared Mar 31, 1995
NTBS-1417, 1436, TBS-1417
K946260 · IXY
Scott Imaging Intl., Inc.
Radiology · 108d
Cleared Mar 31, 1995
UNIVERSAL URETHRAL CATHETER
K946282 · EZC
Louisville Laboratories, Inc.
Gastroenterology & Urology · 94d
Cleared Mar 31, 1995
M-PATH NITINOL GUIDEWIRE
K946356 · DQX
Microvena Corp.
Cardiovascular · 91d
Cleared Mar 31, 1995
REUSABLE TROCAR WITH SAFETY SLEEVE
K950021 · GCJ
L.A.S.E.R., Inc.
General & Plastic Surgery · 86d
Cleared Mar 31, 1995
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE
K950113 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 79d
Cleared Mar 31, 1995
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE
K950141 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Mar 31, 1995
CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE
K950254 · LYY
Cypress Medical Products, Ltd.
General Hospital · 67d
Cleared Mar 31, 1995
CORSINI 9090
K950402 · IXR
C.A.T. DI Corsini G. & C. Spa
Radiology · 58d
Cleared Mar 31, 1995
INFRARED EXPOSURE HAND SWITCH
K950442 · KXJ
Medical X-Ray Intl., Inc.
Radiology · 63d
Cleared Mar 31, 1995
SILVER ULTRA MINI CANAL
K950458 · ESD
Electone, Inc.
Ear, Nose, Throat · 56d
Cleared Mar 31, 1995
LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270
K950571 · IZF
Continental X-Ray Corp.
Radiology · 59d
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID
K950691 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID
K950692 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID
K950693 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 31, 1995
COMPACT-X
K950694 · IZO
Electromed Intl., Ltd.
Radiology · 45d
Cleared Mar 31, 1995
ORAL PROCEDURE PACK
K950743 · EGS
Transidyne General Corp.
Dental · 42d
Cleared Mar 31, 1995
UNITRON MODEL ESTEEM
K950759 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 42d
Cleared Mar 31, 1995
PROPHYLAXIS PACK
K950773 · EGS
Transidyne General Corp.
Dental · 38d
Cleared Mar 31, 1995
SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K950894 · EJH
Argen Precious Metals, Inc.
Dental · 32d
Cleared Mar 31, 1995
KARL STORZ STENT APPLICATOR FORCEPS
K950965 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 29d