FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133321–133344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1989
MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
K885171 · DRO
Andover Medical, Inc.
Cardiovascular · 30d
Cleared Jan 11, 1989
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
K884189 · KHP
Eastman Kodak Company
Chemistry · 98d
Cleared Jan 11, 1989
CIRCON ACMI BICAP III THERAPEUTIC SYSTEM
K884254 · KNS
Circon Acmi
Gastroenterology & Urology · 92d
Cleared Jan 11, 1989
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
K884375 · DQR
Argon Medical Corp.
Cardiovascular · 85d
Cleared Jan 11, 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 11, 1989
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382 · CIW
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 11, 1989
BETA 90/50 MOBILE IMAGING TABLE
K884531 · IXR
Beta Medical Products Co.
Radiology · 75d
Cleared Jan 11, 1989
RELIANT OXYGEN CONCENTRATOR
K884581 · CAW
Airsep Corp.
Anesthesiology · 70d
Cleared Jan 11, 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
CHLORIDE TEST (CL) ITEM #65659
K884706 · CHJ
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)
K884923 · DHB
Diagnostic Products Corp.
Immunology · 47d
Cleared Jan 11, 1989
4060 HA PARTICLES
K885067 · LYC
Bio-Interfaces, Inc.
Dental · 36d
Cleared Jan 11, 1989
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · LDP
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 33d
Cleared Jan 11, 1989
LASER INDIRECT OPHTHALMOSCOPE (LIO)
K885196 · HQE
Coherent Medical Group
Ophthalmic · 26d
Cleared Jan 10, 1989
CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20
K884252 · KNS
Circon Acmi
Gastroenterology & Urology · 91d
Cleared Jan 10, 1989
APA-C CATALOG NUMBER A-8001-C
K884299 · IYO
Ausonics Pty , Ltd.
Radiology · 89d
Cleared Jan 10, 1989
ANGIOPUMP TUBING SET
K884310 · DWF
Olympus Corp.
Cardiovascular · 89d
Cleared Jan 10, 1989
MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER
K884331 · DTC
Medtronic Vascular
Cardiovascular · 88d
Cleared Jan 10, 1989
NORITAKE SUPER PORCELAIN EX-3
K884356 · EIH
Noritake Co., Inc.
Dental · 85d
Cleared Jan 10, 1989
EDENTEC MODEL 4700 SCANNER
K884388 · DSF
Edentec Corp.
Cardiovascular · 84d
Cleared Jan 10, 1989
HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS
K884395 · IYO
Hewlett-Packard Co.
Radiology · 84d
Cleared Jan 10, 1989
CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE
K884481 · LIT
Mallinckroot, Inc.
Cardiovascular · 80d
Cleared Jan 10, 1989
BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED
K884515 · EKJ
Gatewood and Associates, Ltd.
Dental · 75d
Cleared Jan 10, 1989
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
K884590 · KFF
Hemotec, Inc.
Hematology · 68d