FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85801–85824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1999
MODIFIED HAM'S F-10 WITH ALBUMIN
K991420 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 70d
Cleared Jul 02, 1999
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM...
K991421 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 70d
Cleared Jul 02, 1999
WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
K991626 · LLZ
Analogic Corp.
Radiology · 52d
Cleared Jul 01, 1999
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
K983631 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 259d
Cleared Jul 01, 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837 · LPH
Implex Corp.
Orthopedic · 244d
Cleared Jul 01, 1999
THERMAL ANGEL
K984640 · BSB
Estill Medical Technologies, Inc.
Hematology · 182d
Cleared Jul 01, 1999
BIO-INTERFERENCE SCREW
K990454 · HWC
Innovasive Devices, Inc.
Orthopedic · 139d
Cleared Jul 01, 1999
ANESFLOW-DUAL DRIP IV INFUSION SET
K990496 · FPA
Innovative Design Assoc.
General Hospital · 134d
Cleared Jul 01, 1999
RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES
K990602 · QPB
Tecsa Technical Services
General & Plastic Surgery · 127d
Cleared Jul 01, 1999
SYNTHES CERVIFIX SYSTEM
K990965 · KWP
Synthes (Usa)
Orthopedic · 101d
Cleared Jul 01, 1999
CRYO-MONO CRYOGRNIC SYSTEM
K991122 · GEH
Influence, Inc.
General & Plastic Surgery · 90d
Cleared Jul 01, 1999
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
K991169 · DTB
Biotronik, Inc.
Cardiovascular · 85d
Cleared Jul 01, 1999
OPUS TROPONIN I CALIBRATOR
K991176 · JIT
Dade Behring, Inc.
Chemistry · 85d
Cleared Jul 01, 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177 · MMI
Dade Behring, Inc.
Chemistry · 85d
Cleared Jul 01, 1999
MODIFICATION TO TRUZONE PEAK FLOW METER
K991212 · BZH
Monaghan Medical Corp.
Anesthesiology · 83d
Cleared Jul 01, 1999
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
K991275 · FRN
Mckinley, Inc.
General Hospital · 78d
Cleared Jul 01, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K991457 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 66d
Cleared Jul 01, 1999
EXCELL 22
K991539 · GKZ
Mwi, Inc.
Hematology · 59d
Cleared Jul 01, 1999
NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K991821 · LZA
Ning BO Yujiang Rubber & Plastic Co.
General Hospital · 35d
Cleared Jul 01, 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
K991939 · KGO
Brightway Holdings Sdn. Bhd.
General Hospital · 22d
Cleared Jul 01, 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR...
K991953 · BTM
Engineered Medical Systems
Anesthesiology · 30d
Cleared Jul 01, 1999
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
K992058 · JDI
Biomet, Inc.
Orthopedic · 13d
Cleared Jun 30, 1999
MCKINLEY SP DISPOSABLE INFUSION PUMP
K990461 · MEB
Mckinley, Inc.
General Hospital · 138d
Cleared Jun 30, 1999
DIFOTI SYSTEM
K991098 · EIA
Electro-Optical Sciences, Inc.
Dental · 90d