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
94057–94080 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1997
EUB-8000
K954220 · IYN
Hitachi Medical Corp. of America
Radiology · 604d
Cleared May 07, 1997
MAGNES 2500 WH BIOMAGNETOMETER
K962317 · OLY
Biomagnetic Technologies, Inc.
Neurology · 324d
Cleared May 07, 1997
WRIGHT PLASTER OF PARIS PELLETS
K963562 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 244d
Cleared May 07, 1997
VAIL 2000 ENCLOSED BED
K963622 · FNL
Vail Products, Inc.
General Hospital · 239d
Cleared May 07, 1997
VISTA BRITE TIP CATHETERS
K963962 · DQY
Cordis Corp.
Cardiovascular · 217d
Cleared May 07, 1997
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K964814 · DYB
Bipore, Inc.
Cardiovascular · 159d
Cleared May 07, 1997
SIMPLEX AIRBRATOR
K970249 · KOJ
Simplex Medical Systems, Inc.
Dental · 105d
Cleared May 07, 1997
INFANT RADIANT WARMER - MODELS IW910 AND IW920
K970432 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 92d
Cleared May 07, 1997
LACTATE DEHYDROGENASE (LD)
K970684 · CFJ
Randox Laboratories, Ltd.
Chemistry · 72d
Cleared May 07, 1997
KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT
K970738 · IZI
Jamieson Film Co.
Radiology · 68d
Cleared May 07, 1997
ANGLED TIP POLYPECTOMY SNARE
K970945 · KNS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 54d
Cleared May 07, 1997
WAKO DIRECT BILIRUBIN V
K970986 · CIG
Wako Chemicals USA, Inc.
Chemistry · 50d
Cleared May 06, 1997
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
K955622 · LHI
Baxter Healthcare Corp
General Hospital · 512d
Cleared May 06, 1997
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816 · DYG
Baxter Healthcare Corp
Cardiovascular · 497d
Cleared May 06, 1997
STERITITE SEALED...
K960738 · KCT
Engineered Custom Mfg., Inc.
General Hospital · 438d
Cleared May 06, 1997
BIOSPHERE SUTURE ANCHOR
K963396 · MAI
Instrument Makar, Inc.
Orthopedic · 251d
Cleared May 06, 1997
3F ANGIOPTIC ANGIOGRAPHIC CATHETER
K964033 · DQO
AngioDynamics, Inc.
Cardiovascular · 210d
Cleared May 06, 1997
TRANSJUGULAR ACCESS SET
K964034 · DYB
AngioDynamics, Inc.
Cardiovascular · 210d
Cleared May 06, 1997
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · FXX
Depuy, Inc.
General Hospital · 203d
Cleared May 06, 1997
HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT
K964188 · JOW
Healthcare Service and Supply
Cardiovascular · 197d
Cleared May 06, 1997
CYGNUS INSTRUMENT PROTECTORS
K964256 · FRG
Madison Polymeric Engineering
General Hospital · 193d
Cleared May 06, 1997
FLOSSBRUSH WITH FLUORIDE
K964976 · JES
Flossbrush Interdental Cleaner and...
Dental · 145d
Cleared May 06, 1997
SANI-SHIELD
K970104 · EFB
Dw Industries, Inc.
Dental · 113d
Cleared May 06, 1997
EVEREST SUNGLASSES
K970315 · HQY
Ycc International Corp.
Ophthalmic · 99d