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
97489–97512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1996
QUANTASE PHENYLALANINE ASSAY
K961515 · JNB
Shield Diagnostics, Ltd.
Chemistry · 63d
Cleared Jun 11, 1996
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
K955104 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 216d
Cleared Jun 11, 1996
BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC
K961040 · FJI
Dayspring Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 11, 1996
ESOPHAGEAL MANOMETRY ANALYSIS MODULE
K961070 · KLA
Synectics Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 11, 1996
UPACS VERSION 1.7
K961160 · LMB
Base Ten Systems, Inc.
Radiology · 81d
Cleared Jun 11, 1996
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
K961301 · DQD
Delphi Consulting Group
Cardiovascular · 68d
Cleared Jun 11, 1996
ELECSYS FT4 ASSAY
K961489 · CEC
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Jun 11, 1996
ELECSYS TROPONIN T
K961500 · MMI
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Jun 11, 1996
ELECSYS CK-MB
K961501 · JHW
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Jun 11, 1996
WET-PREP
K961822 · KLE
Bisco, Inc.
Dental · 32d
Cleared Jun 11, 1996
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
K961828 · JJT
Bio-Rad
Chemistry · 29d
Cleared Jun 11, 1996
TYMPANOSTOMY VENTILATION TUBE
K961945 · ETD
Advanced Microbotics Corp.
Ear, Nose, Throat · 22d
Cleared Jun 11, 1996
AQ HYDROPHILIC UROLOGICAL CATHETERS
K962004 · EYB
Cook Urological, Inc.
Gastroenterology & Urology · 20d
Cleared Jun 10, 1996
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN...
K936135 · LAT
Sudormed, Inc.
Chemistry · 895d
Cleared Jun 10, 1996
LESE STENTS SETS
K952513 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 377d
Cleared Jun 10, 1996
MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
K955389 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Jun 10, 1996
OSTAR
K955424 · LYY
Ultravena Industries, Ltd.
General Hospital · 195d
Cleared Jun 10, 1996
CRYTRON SYSTEM
K955529 · ILO
Mark H. Friedman
Physical Medicine · 189d
Cleared Jun 10, 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634 · CBP
Boston Medical Products, Inc.
Anesthesiology · 182d
Cleared Jun 10, 1996
OSTAR EXAMINATION GLOVES
K955947 · LYY
Contract Latex Dippers Sdn Bhd
General Hospital · 195d
Cleared Jun 10, 1996
BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL
K961026 · FJI
Dayspring Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 10, 1996
JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
K961227 · FRG
J.J. Skinner, Inc.
General Hospital · 74d
Cleared Jun 10, 1996
POS-T-VAC ID-300
K961309 · KZH
Pos-T-Vac, Inc.
General Hospital · 67d
Cleared Jun 10, 1996
TONGUE SCRAPPER
K961574 · LCN
U.S. Dentek Corp.
Dental · 48d