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
96985–97008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1996
CW-DISPOSABLE ACUPUNCTURE NEEDLE
K962419 · MQX
Acupuncture Supplies Import Co.
General Hospital · 31d
Cleared Jul 25, 1996
(BRAND NAME) SUNGLASS FRAMES
K962478 · HQY
Custom Optical Frames, Inc.
Ophthalmic · 30d
Cleared Jul 25, 1996
MODEL SL-YZ5E
K962522 · HJO
Pacific Ophthalmic Supply
Ophthalmic · 41d
Cleared Jul 25, 1996
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
K962532 · HJO
Expertech Assoc., Inc.
Ophthalmic · 27d
Cleared Jul 25, 1996
SUNGLASSES, GAUDI SUN LINE
K962636 · HQY
Gaudi Spa
Ophthalmic · 20d
Cleared Jul 25, 1996
MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
K962688 · KCF
Boston Medical Products, Inc.
Ear, Nose, Throat · 14d
Cleared Jul 25, 1996
SOMA
K962725 · HQY
Soma International , Ltd.
Ophthalmic · 10d
Cleared Jul 25, 1996
SUNGLASSES (NON-PRESCRIPTION)
K962775 · HQY
Canadd Trading Co.
Ophthalmic · 9d
Cleared Jul 24, 1996
ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
K951851 · LJO
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 460d
Cleared Jul 24, 1996
CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM
K954432 · DZE
Crystal Medical Technology
Dental · 303d
Cleared Jul 24, 1996
DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
K954713 · FGE
Ideas For Medicine, Inc.
Gastroenterology & Urology · 288d
Cleared Jul 24, 1996
INCSTAR HSV I/II IGG FAST ELISA ASSAY
K955362 · IGC
Incstar Corp.
Microbiology · 245d
Cleared Jul 24, 1996
INCSTAR HSZ I/II IGG ELISA ASSAY
K955363 · IGC
Incstar Corp.
Microbiology · 245d
Cleared Jul 24, 1996
XRT 400
K955414 · KXJ
Wuestec Medical, Inc.
Radiology · 240d
Cleared Jul 24, 1996
MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
K960083 · IXQ
Wuestec Medical, Inc.
Radiology · 195d
Cleared Jul 24, 1996
DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
K960176 · FEG
C.R. Bard, Inc.
Gastroenterology & Urology · 190d
Cleared Jul 24, 1996
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
K960936 · HET
Origin Medsystems, Inc.
Obstetrics & Gynecology · 138d
Cleared Jul 24, 1996
VZV IGG ELISA TEST SYSTEM
K961012 · LFY
Zeus Scientific, Inc.
Microbiology · 133d
Cleared Jul 24, 1996
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 106d
Cleared Jul 24, 1996
MEDLINE TITANIUM HEMOCLIPS
K962016 · FZP
Medline Industries, Inc.
General & Plastic Surgery · 62d
Cleared Jul 24, 1996
TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
K962047 · JDS
Synthes (Usa)
Orthopedic · 57d
Cleared Jul 24, 1996
POLARUS AF ROD
K962091 · HSB
Acu Med, Inc.
Orthopedic · 56d
Cleared Jul 24, 1996
SENTRY RADIOTRANSLUCENT ECG ELECTRODES
K962122 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 54d
Cleared Jul 24, 1996
STERNGOLD U-CPF METAL ALLOY (1067800)
K962324 · EJS
Sterngold/Implamed
Dental · 37d