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
116761–116784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1992
CERADELTA 2
K921794 · EJT
Metalor Dental USA Corp.
Dental · 83d
Cleared Jul 02, 1992
ELISA TUBE TSH TEST
K921958 · JLW
Bio Clinic Co.
Chemistry · 66d
Cleared Jul 02, 1992
LEWICKY O.R.S. TUBING
K922180 · KYG
O.R. Specialties, Inc.
Ophthalmic · 55d
Cleared Jul 02, 1992
OLYMPUS TRIGLYCERIDE REAGENT
K922229 · CDT
Olympus Corp.
Chemistry · 51d
Cleared Jul 02, 1992
AGA TRACH TIES
K922657 · CBH
Aga Medical Products, Inc.
Anesthesiology · 29d
Cleared Jul 01, 1992
SENSITITRE ARIS MODULE
K911419 · LRG
Sensititre , Ltd.
Microbiology · 457d
Cleared Jul 01, 1992
TTL MEDICATED DRESSING
K914733 · KGX
Medimix Products, Inc.
General & Plastic Surgery · 254d
Cleared Jul 01, 1992
MEGACART
K915225 · LOS
Siemens Burdick, Inc.
Cardiovascular · 224d
Cleared Jul 01, 1992
TRANSDUCER PROTECTOR
K915593 · FIB
United Pharmaceutical and Medical...
Gastroenterology & Urology · 201d
Cleared Jul 01, 1992
THERMUFF BAG
K920153 · KDC
Techstyles
General & Plastic Surgery · 170d
Cleared Jul 01, 1992
SUNGLASSES
K920807 · HQY
Libby Lee Toys, Inc.
Ophthalmic · 131d
Cleared Jul 01, 1992
UROLOGICAL BALLOON DILATATION CATHETER
K920946 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 121d
Cleared Jul 01, 1992
HEALEY REVISION COMPONENT SYSTEM
K921139 · JDL
Biomet, Inc.
Orthopedic · 113d
Cleared Jul 01, 1992
CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM
K921563 · ITX
Cardio Metrics, Inc.
Radiology · 91d
Cleared Jul 01, 1992
INTEGRATED VIDEO SYSTEM
K921692 · HRX
Citation Medical Corp.
Orthopedic · 84d
Cleared Jul 01, 1992
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
K921707 · EOB
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 82d
Cleared Jul 01, 1992
KODAK EKTASCAN 2180 LASER PRINTER
K921743 · LMC
Eastman Kodak Company
Radiology · 79d
Cleared Jul 01, 1992
AD/V SPOOLER
K921877 · LMD
Adaptive Video, Inc.
Radiology · 72d
Cleared Jul 01, 1992
SDMO APPLICATOR CODE: ASN.8236
K921961 · IWJ
Medi-Physics Inc. Dba Nycomed...
Radiology · 65d
Cleared Jul 01, 1992
BACTEC 9120 SYSTEM
K922475 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Jul 01, 1992
DIGITIZER, MODEL # 3-000A-1518
K922619 · IZH
Lorad Medical Systems, Inc.
Radiology · 33d
Cleared Jul 01, 1992
OTOSONIC ACS K
K922827 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 19d
Cleared Jun 30, 1992
SD-200IEHL(TM)
K914517 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 265d
Cleared Jun 30, 1992
#903 SILAFLEX II
K915739 · EWD
Flents Products Co., Inc.
Ear, Nose, Throat · 197d