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
88753–88776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1998
CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982520 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982523 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982524 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982526 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982528 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982669 · JTN
Oxoid , Ltd.
Microbiology · 40d
Cleared Sep 09, 1998
LIGHT SABER BONE BIOPSY NEEDLE
K982735 · KNW
Minrad, Inc.
Gastroenterology & Urology · 35d
Cleared Sep 09, 1998
MAXAIR NASAL DILATOR SYSTEM
K982929 · LWF
Hnl Technologies
Ear, Nose, Throat · 20d
Cleared Sep 08, 1998
CARDIOVIEW 3000 SOFTWARE
K974352 · LOS
Micromedical, Inc.
Cardiovascular · 293d
Cleared Sep 08, 1998
ENDO ABSORBABLE INTERFERENCE SCREW
K980457 · HWC
Endo Surgical Concepts, Inc.
Orthopedic · 215d
Cleared Sep 08, 1998
ALIGN SYSTEM
K981095 · NXC
Align Technology
Dental · 166d
Cleared Sep 08, 1998
OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE
K982031 · GEX
Iridex Corp
General & Plastic Surgery · 90d
Cleared Sep 08, 1998
MEDPOR SURGICAL GRANULE IMPLANTS
K982040 · GXP
Porex Surgical, Inc.
Neurology · 90d
Cleared Sep 08, 1998
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
K982042 · OTN
Island Biosurgical, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 08, 1998
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
K982055 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 89d
Cleared Sep 08, 1998
AQUACEL HYDROFIBER WOUND DRESSING
K982116 · KMF
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 84d
Cleared Sep 08, 1998
AL-GEN CALCIUM ALGINATE DRESSING
K982234 · KMF
Innovative Technologies , Ltd.
General & Plastic Surgery · 75d
Cleared Sep 08, 1998
MAMMARY SIZER
K982258 · MRD
Specialty Surgical Products, Inc.
General & Plastic Surgery · 74d
Cleared Sep 08, 1998
RADIAL HEAD IMPLANT
K982288 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 70d
Cleared Sep 08, 1998
PROSTATE BIOPSY NEEDLE
K982401 · KNW
Remington Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Sep 08, 1998
PROXIDERM, MODELS TN 460, TN 90 460, BK 460
K982439 · MKY
Progressive Surgical Products, Inc.
General & Plastic Surgery · 56d
Cleared Sep 08, 1998
MODULAP
K982445 · GCJ
Atc Medical Technology, Inc.
General & Plastic Surgery · 55d
Cleared Sep 08, 1998
BWM SPINE SYSTEM
K982494 · KWP
Howmedica Corp.
Orthopedic · 53d
Cleared Sep 08, 1998
IPS EMPRESS 2
K982616 · EIH
Ivoclar North America, Inc.
Dental · 43d