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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133921–133944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1988
PROCEDURE PACKS SOLUTION ADMINISTRATION SETS
K882716 · DQD
Procedure Packs, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Sep 16, 1988
ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST
K882803 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Sep 16, 1988
POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP
K883016 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 59d
Cleared Sep 16, 1988
INTERSEPT*PREBYPASS FILTER
K883086 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 57d
Cleared Sep 16, 1988
PERFORMED CROWN (STAINLESS STEEL)
K883325 · ELZ
Whitecap Dental Co.
Dental · 42d
Cleared Sep 16, 1988
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558 · JSS
Vitek Systems, Inc.
Microbiology · 28d
Cleared Sep 16, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110
K883650 · LNH
Instrumentarium Corp.
Radiology · 18d
Cleared Sep 16, 1988
CHANG MEDIUM (ADDITIONAL INDICATIONS)
K883682 · KIT
Hana Biologics, Inc.
Pathology · 18d
Cleared Sep 15, 1988
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
K881811 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 140d
Cleared Sep 15, 1988
CANON IOL ESTIMATOR KU-1
K881889 · IYO
Canon USA, Inc.
Radiology · 133d
Cleared Sep 15, 1988
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Sep 15, 1988
EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM
K882605 · HIB
Buckman Co., Inc.
Obstetrics & Gynecology · 83d
Cleared Sep 15, 1988
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
K882721 · ESD
Hear-O Inc. C/O L.P. Leale & Assoc.
Ear, Nose, Throat · 76d
Cleared Sep 15, 1988
VITRABOND LIGHT CURE GLASS IONOMER LINER
K882821 · EKJ
3M Company
Dental · 69d
Cleared Sep 15, 1988
SITE MACROBORE PHACO NEEDLE
K883099 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 55d
Cleared Sep 15, 1988
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
K883199 · HQC
Chiron Vision Corp.
Ophthalmic · 49d
Cleared Sep 15, 1988
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
K883213 · HQF
Nidek, Inc.
Ophthalmic · 48d
Cleared Sep 15, 1988
KOMET SURGICAL BUR
K883255 · GFF
Komet Medical, Div. of Brasseler USA...
General & Plastic Surgery · 44d
Cleared Sep 15, 1988
COUNT-A-DOSE
K883311 · FMF
Pavel Jordan & Associates, Inc.
General Hospital · 41d
Cleared Sep 15, 1988
HERAEUS C SPECIAL
K883507 · EJS
Degussa Dental, Inc.
Dental · 29d
Cleared Sep 15, 1988
DEGUPAL 4
K883510 · EJS
Degussa Dental, Inc.
Dental · 29d
Cleared Sep 15, 1988
OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.
K883613 · GDC
Stierlen-Maquet AG
General & Plastic Surgery · 24d
Cleared Sep 15, 1988
CYTOGUARD(R)
K883614 · FMF
Survival Technology, Inc.
General Hospital · 22d