FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
111289–111312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1994
PHACOFRAGMENTOR TIP
K933627 · HQC
M. Imonti and Associates Inc.,
Ophthalmic · 182d
Cleared Jan 25, 1994
ENDOSCOPIC NEEDLE DRIVER
K933725 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 176d
Cleared Jan 25, 1994
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
K933984 · HQE
Storz Instrument Co.
Ophthalmic · 162d
Cleared Jan 25, 1994
PHX TECHOLOGIES CORP., 5MM STERILE, DISPOSABLE ENDOSCOPIC KITTNER BLUNT...
K934077 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 158d
Cleared Jan 25, 1994
STERILE, DISPOSABLE ENDO SPECIEMEN RETRIEVAL BAG
K934165 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 154d
Cleared Jan 25, 1994
SPECTACLE FRAMES AND SUNGLASSES
K934187 · HQZ
Wah Ming Optical Mfy. , Ltd.
Ophthalmic · 152d
Cleared Jan 25, 1994
OPTIKOS SHAMI, INC. SUNGLASSES
K934197 · HQY
Optikos Shami, Inc.
Ophthalmic · 152d
Cleared Jan 25, 1994
COOL KIDS MIRROR SHADES
K934402 · HQY
Ja-Ru, Inc.
Ophthalmic · 138d
Cleared Jan 25, 1994
HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION
K934485 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 133d
Cleared Jan 25, 1994
SURGITEL
K934494 · HOH
General Scientific Corp.
Ophthalmic · 132d
Cleared Jan 25, 1994
OLYMPUS IMAGEMANAGERSYSTEM
K934888 · LMB
Olympus
Radiology · 104d
Cleared Jan 25, 1994
ELECTRIC I/V POLE OR EIVP2
K935003 · KYG
Optical Micro Systems, Inc.
Ophthalmic · 98d
Cleared Jan 25, 1994
HEPA FILTERED HEAT AND MOISTURE EXCHANGER
K935036 · BYD
Intertech Resources, Inc.
Anesthesiology · 118d
Cleared Jan 25, 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 96d
Cleared Jan 25, 1994
GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS
K935070 · FCL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 92d
Cleared Jan 25, 1994
SPECTACLE FRAMES
K935107 · HQZ
Mr I'S Optical Boutique
Ophthalmic · 95d
Cleared Jan 25, 1994
TALE SPIN SUNSHADES
K935231 · HQY
Equity Marketing, Inc.
Ophthalmic · 85d
Cleared Jan 25, 1994
GAUZE DRESSING
K935241 · EFQ
Chak Tak (Shen Zhen) Enterprises, Ltd.
General & Plastic Surgery · 85d
Cleared Jan 25, 1994
SPECTACLE FRAME/EYEGLASS FRAME
K935558 · HQZ
Modern Optical , Ltd.
Ophthalmic · 69d
Cleared Jan 25, 1994
TEC 2100 (MODEL MT-LPLGD)
K935760 · IWE
Medtec, Inc.
Radiology · 60d
Cleared Jan 25, 1994
CEDIA DAU 5-DRUG CALIBRATORS
K935792 · DKB
Microgenics Corp.
Toxicology · 49d
Cleared Jan 25, 1994
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
K935794 · DKB
Microgenics Corp.
Toxicology · 49d
Cleared Jan 25, 1994
UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE
K936136 · JAA
Ge Dec Medical Systems
Radiology · 34d
Cleared Jan 24, 1994
AEROCHAMBER W/MASK, MODIFIED
K930574 · CAF
Monaghan Medical Corp.
Anesthesiology · 354d