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

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174,955 results
93145–93168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1997
AMO DIPLOMAX/OPSYS CONSOLE
K971186 · HQC
Allergan, Inc.
Ophthalmic · 73d
Cleared Jun 13, 1997
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT
K971230 · KNT
Innerdyne, Inc.
Gastroenterology & Urology · 72d
Cleared Jun 13, 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · HRX
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jun 13, 1997
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET
K971274 · CAC
Fresenius AG
Anesthesiology · 67d
Cleared Jun 13, 1997
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
K971399 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 59d
Cleared Jun 13, 1997
SUNGLASSES (NON-PRESCRIPTION)
K971707 · HQY
Niko Sunglasses Corp.
Ophthalmic · 38d
Cleared Jun 13, 1997
ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER,...
K971805 · GEI
Aaron Medical Industries
General & Plastic Surgery · 29d
Cleared Jun 13, 1997
OPTIM-EYES 450
K971875 · HQY
Taylor/Fox Enterprises, LLC
Ophthalmic · 24d
Cleared Jun 11, 1997
BIO-GIDE RESORBABLE BILAYER MEMBRANE
K960724 · NPK
Geistlich-Pharma
Dental · 475d
Cleared Jun 11, 1997
ASPISAFE GASTRIC TUBE
K961711 · BSS
B.Braun Medical, Inc.
Gastroenterology & Urology · 405d
Cleared Jun 11, 1997
DURATION STABILIZED UHMWPE
K963612 · JDI
Howmedica Corp.
Orthopedic · 274d
Cleared Jun 11, 1997
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
K963653 · HGI
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 272d
Cleared Jun 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
K964842 · CZW
Beckman Instruments, Inc.
Immunology · 190d
Cleared Jun 11, 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K965173 · JWH
Howmedica Corp.
Orthopedic · 169d
Cleared Jun 11, 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177 · MID
Immco Diagnostics, Inc.
Immunology · 145d
Cleared Jun 11, 1997
CB ERBIUM/2.94(TM) ER:YAG LASER
K970934 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Jun 11, 1997
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
K970955 · KWQ
Acromed Corp.
Orthopedic · 86d
Cleared Jun 11, 1997
OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
K971061 · LRO
Opportunity, Inc.
General & Plastic Surgery · 79d
Cleared Jun 11, 1997
KANEDA SR ANTERIOR SPINAL SYSTEM
K971248 · KWQ
Acromed Corp.
Orthopedic · 69d
Cleared Jun 11, 1997
PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
K971334 · GCJ
Pilling Weck Group
General & Plastic Surgery · 62d
Cleared Jun 11, 1997
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
K971444 · DRX
3M Medical Products Group
Cardiovascular · 51d
Cleared Jun 11, 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505 · CHH
Beckman Instruments, Inc.
Chemistry · 47d
Cleared Jun 11, 1997
VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L...
K971674 · GEI
Aaron Medical Industries
General & Plastic Surgery · 35d
Cleared Jun 11, 1997
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · LAN
Bayer Corp.
Toxicology · 33d