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
93553–93576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1997
KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT
K970738 · IZI
Jamieson Film Co.
Radiology · 68d
Cleared May 07, 1997
ANGLED TIP POLYPECTOMY SNARE
K970945 · KNS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 54d
Cleared May 07, 1997
WAKO DIRECT BILIRUBIN V
K970986 · CIG
Wako Chemicals USA, Inc.
Chemistry · 50d
Cleared May 06, 1997
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
K955622 · LHI
Baxter Healthcare Corp
General Hospital · 512d
Cleared May 06, 1997
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816 · DYG
Baxter Healthcare Corp
Cardiovascular · 497d
Cleared May 06, 1997
STERITITE SEALED...
K960738 · KCT
Engineered Custom Mfg., Inc.
General Hospital · 438d
Cleared May 06, 1997
BIOSPHERE SUTURE ANCHOR
K963396 · MAI
Instrument Makar, Inc.
Orthopedic · 251d
Cleared May 06, 1997
3F ANGIOPTIC ANGIOGRAPHIC CATHETER
K964033 · DQO
AngioDynamics, Inc.
Cardiovascular · 210d
Cleared May 06, 1997
TRANSJUGULAR ACCESS SET
K964034 · DYB
AngioDynamics, Inc.
Cardiovascular · 210d
Cleared May 06, 1997
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · FXX
Depuy, Inc.
General Hospital · 203d
Cleared May 06, 1997
HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT
K964188 · JOW
Healthcare Service and Supply
Cardiovascular · 197d
Cleared May 06, 1997
CYGNUS INSTRUMENT PROTECTORS
K964256 · FRG
Madison Polymeric Engineering
General Hospital · 193d
Cleared May 06, 1997
FLOSSBRUSH WITH FLUORIDE
K964976 · JES
Flossbrush Interdental Cleaner and...
Dental · 145d
Cleared May 06, 1997
SANI-SHIELD
K970104 · EFB
Dw Industries, Inc.
Dental · 113d
Cleared May 06, 1997
EVEREST SUNGLASSES
K970315 · HQY
Ycc International Corp.
Ophthalmic · 99d
Cleared May 06, 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 95d
Cleared May 06, 1997
LAXIMA INTERNATIONAL LIMITED SUNGLASSES
K970454 · HQY
Laxima Intl., Ltd.
Ophthalmic · 90d
Cleared May 06, 1997
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL...
K970463 · DTZ
Terumo Medical Corp.
Cardiovascular · 89d
Cleared May 06, 1997
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)
K970476 · HQY
Hwa Mao Optical Co., Ltd.
Ophthalmic · 88d
Cleared May 06, 1997
CORDIS OPTA5 PTA BALLOON CATHETER
K970620 · LIT
Cordis Corp.
Cardiovascular · 77d
Cleared May 06, 1997
REUSABLE VITRECTOMY PROBE
K970670 · HQE
Altex Vision
Ophthalmic · 71d
Cleared May 06, 1997
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
K970698 · HQD
Polymer Technology Corp.
Ophthalmic · 70d
Cleared May 06, 1997
SOLAR SPECS
K970759 · HQY
Morris Rosenbloom & Co., Inc.
Ophthalmic · 64d
Cleared May 06, 1997
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 63d