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
88249–88272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 08, 1998
JUMBO SILVER-REINFORCED GLASS IONOMER
K982665 · EMA
Centrix, Inc.
Dental · 46d
Cleared Sep 08, 1998
MIDAS TOUCH BIPOLAR FORCEPS
K982705 · GEI
Iti Medical Technologies, Inc.
General & Plastic Surgery · 36d
Cleared Sep 08, 1998
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT
K982865 · NPK
Atrix Laboratories, Inc.
Dental · 26d
Cleared Sep 08, 1998
QUICK TAP SELF DRILLING SCREW
K982927 · DZL
Kinamed, Inc.
Dental · 19d
Cleared Sep 04, 1998
BIOSENSORS EMBOLECTOMY CATHETER
K973477 · DXE
Sunscope Intl., Inc.
Cardiovascular · 354d
Cleared Sep 04, 1998
FRIALIT-2 CORABASE
K980630 · DZE
Friatec AG
Dental · 198d
Cleared Sep 04, 1998
EVITA 4 (8411900)
K980642 · CBK
Drager, Inc.
Anesthesiology · 197d
Cleared Sep 04, 1998
HEARTPORT ENDOPULMONARY VENT CATHETER
K981009 · DWF
Heartport, Inc.
Cardiovascular · 170d
Cleared Sep 04, 1998
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
K981314 · DJR
Sun Biomedical Laboratories, Inc.
Chemistry · 147d