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
101833–101856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1995
GLOWING SPIRITS
K951239 · DYW
Ormco Corp.
Dental · 121d
Cleared Jul 19, 1995
METAL URETERAL BASKET STONE DISLODGER
K951532 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 107d
Cleared Jul 19, 1995
STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)
K951824 · HQC
Nidek, Inc.
Ophthalmic · 90d
Cleared Jul 19, 1995
ADMINISTRATION SETS WITH BALL FLOAT
K951922 · FPA
Imed Corp.
General Hospital · 86d
Cleared Jul 19, 1995
IMX DIGOXIN
K952079 · KXT
Abbott Laboratories
Toxicology · 77d
Cleared Jul 19, 1995
ENDOPORE DENTAL IMPLANT ABUTMENTS
K952434 · DZE
Innova Corp.
Dental · 56d
Cleared Jul 19, 1995
XXL BALLOON DILATATION CATHETER
K952656 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 72d
Cleared Jul 19, 1995
KENLOR LIQUID TOTAL URINE CONTROL
K952840 · JJW
Kenlor Industries, Inc.
Chemistry · 28d
Cleared Jul 19, 1995
FORCEPS, BIOPSY, NON-ELECTRIC
K952863 · FCL
Annex Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Jul 19, 1995
DENTAURUM JACKET CROWN & ROOT POSTS
K952868 · EBL
Dentauraum, Inc.
Dental · 27d
Cleared Jul 19, 1995
PULPDENT POST CEMENT
K952960 · EMA
Pulpdent Corp.
Dental · 23d
Cleared Jul 19, 1995
PERMADYNE PENTA (HIGH & LOW VISCOSITY)
K953027 · ELW
Espe GmbH & Co. Kg.
Dental · 20d
Cleared Jul 19, 1995
FOSTER GRANT NON PRESCRIPTION SUNGLASSES
K953092 · HQY
Foster Grant Group
Ophthalmic · 16d
Cleared Jul 19, 1995
NYX GOLF VISION SYSTEM
K953245 · HQY
Nyx Golf, Inc.
Ophthalmic · 12d
Cleared Jul 19, 1995
SUNGLASSES
K953260 · HQY
Eye Deals
Ophthalmic · 7d
Cleared Jul 18, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K934458 · JWY
Baxter Diagnostics, Inc.
Microbiology · 673d
Cleared Jul 18, 1995
HSS FEMORAL COMPONENTS
K934857 · JDI
Hospital For Special Surgery
Orthopedic · 644d
Cleared Jul 18, 1995
INFUSION PUMP
K941418 · MEB
I-Flow Corp.
General Hospital · 482d
Cleared Jul 18, 1995
HM-CAP EIA KIT
K944159 · LYR
Schiff & Co.
Microbiology · 326d
Cleared Jul 18, 1995
QUANTA LITE(TM) IGG (HRP)
K946034 · MID
Inova Diagnostics, Inc.
Immunology · 221d
Cleared Jul 18, 1995
IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER
K946333 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 201d
Cleared Jul 18, 1995
QUANTA LITE ACA IGM (HRP)
K946385 · MID
Inova Diagnostics, Inc.
Immunology · 221d
Cleared Jul 18, 1995
CONAIR FAMILY FITNESS BODY ENERGY
K950441 · IRO
Conair Corp.
Physical Medicine · 172d
Cleared Jul 18, 1995
NEXMED CANCELLOUS BONE SCREWS
K951656 · HWC
Nexmed, Inc.
Orthopedic · 99d