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
91777–91800 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1997
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA...
K973861 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 41d
Cleared Nov 19, 1997
CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
K974190 · IMD
Consolidated Products & Services, Inc.
Physical Medicine · 15d
Cleared Nov 18, 1997
SAFPACE SYSTEM
K955829 · LDF
B.Braun Medical, Inc.
Cardiovascular · 693d
Cleared Nov 18, 1997
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
K970107 · EOQ
Urohealth Systems, Inc.
Ear, Nose, Throat · 309d
Cleared Nov 18, 1997
ELVIS HSV ID/TYPING TEST SYSTEM
K971662 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 203d
Cleared Nov 18, 1997
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
K972517 · KGI
Lunar Corp.
Radiology · 134d
Cleared Nov 18, 1997
Hi Coat Powder Free Latex Patient Examination Gloves
K972539 · LYY
P.T. Latexindo Tobaperkasa
General Hospital · 133d
Cleared Nov 18, 1997
SIMPULSE
K972549 · FNM
Kinetic Concepts, Inc.
General Hospital · 133d
Cleared Nov 18, 1997
ULTRACELL PACKING WITH SLEEVE
K973085 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 92d
Cleared Nov 18, 1997
INTERAX TOTAL KNEE SYSTEM
K973121 · JWH
Howmedica Corp.
Orthopedic · 90d
Cleared Nov 18, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K973128 · FOG
Olympus America, Inc.
Anesthesiology · 89d
Cleared Nov 18, 1997
IMTEC BONE TAC
K973180 · DZL
Imtec Corp.
Dental · 85d
Cleared Nov 18, 1997
SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
K973293 · MPA
Vaughan Weeks
Ophthalmic · 77d
Cleared Nov 18, 1997
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401 · DQO
Cordis Corp.
Cardiovascular · 70d
Cleared Nov 18, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER
K973656 · EMX
Specialty Surgical Products, Inc.
Ear, Nose, Throat · 54d
Cleared Nov 18, 1997
VINYL PATIENT EXAMINATION GLOVES POWDERED
K973902 · LYZ
Everrise Glove Products Co., Ltd.
General Hospital · 35d
Cleared Nov 18, 1997
SUNGLASSES
K973934 · HQY
Elegance Optical Manufactory, Ltd.
Ophthalmic · 34d
Cleared Nov 18, 1997
VINYL PATIENT EXAMINATION GLOVES POWDER-FREE
K973998 · LYZ
Everrise Glove Products Co., Ltd.
General Hospital · 28d
Cleared Nov 17, 1997
HYDROTEC LOW AIR LOSS THERAPY BED
K970363 · IOQ
Apex Metal, Inc.
Physical Medicine · 290d
Cleared Nov 17, 1997
AIRTEC2 LOW AIR LOSS THERAPY BED
K970364 · IOQ
Apex Metal, Inc.
Physical Medicine · 290d
Cleared Nov 17, 1997
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST...
K970505 · JOZ
Dade Intl., Inc.
Hematology · 280d
Cleared Nov 17, 1997
HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES...
K970938 · DQX
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 249d
Cleared Nov 17, 1997
VITAL-PORT INFUSION PAL
K971140 · LJT
Med Institute, Inc.
General Hospital · 234d
Cleared Nov 17, 1997
CHAD TOTAL O2 DELIVERY SYSTEM
K971889 · CAW
Chad Therapeutics, Inc.
Anesthesiology · 180d