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

58 results for "Gyrus Acmi, Inc."
25–48 of 58
Search insights Median review: 110d Cleared: 100% Top manufacturer: Gyrus Acmi, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2016
DIEGO ELITE DRILL
K152744 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 261d
Cleared May 06, 2016
Monopolar single-use HF cable
K160053 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 116d
Cleared May 04, 2016
Electrosurgical Generator ESG-200
K160639 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 58d
Cleared Feb 26, 2016
THUNDERBEAT Open Fine Jaw
K151743 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 242d
Cleared Jan 15, 2016
InstaClear Lens Cleaner
K152531 · EOB
Gyrus Acmi, Inc.
Ear, Nose, Throat · 134d
Cleared Dec 17, 2015
PK AIM
K152219 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 132d
Cleared Oct 26, 2015
Resection Electrodes
K152092 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 90d
Cleared Jan 13, 2015
PK Cutting Forceps for ESG-400 Workstation
K142759 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 110d
Cleared Jan 08, 2015
PK J-HOOK
K142350 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 139d
Cleared Dec 31, 2014
PK Spatula
K142289 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 135d
Cleared Dec 19, 2014
PK NEEDLE
K142154 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 135d
Cleared Nov 21, 2014
PK Lap Loop
K142525 · HIN
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 74d
Cleared Feb 04, 2014
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
K132383 · LJE
Gyrus Acmi, Inc.
Gastroenterology & Urology · 188d
Cleared Apr 05, 2013
OLYMPUS ENERGY POWER SYSTEM (EPS)
K123429 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 149d
Cleared Dec 05, 2012
PKS BILL
K122605 · HIN
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 100d
Cleared Aug 30, 2012
DTAD
K121678 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 84d
Cleared Jul 10, 2012
GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
K120474 · KCT
Gyrus Acmi, Inc.
General Hospital · 145d
Cleared Jun 20, 2012
GYRUS AMCI PK BUTTON ELECTRODE
K120567 · FAS
Gyrus Acmi, Inc.
Gastroenterology & Urology · 114d
Cleared Sep 01, 2011
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
K111059 · HIN
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 136d
Cleared Jul 19, 2011
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K110852 · HIG
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 113d
Cleared May 20, 2011
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
K102970 · KCT
Gyrus Acmi, Inc.
General Hospital · 226d
Cleared Oct 20, 2010
GYRUS ACMI BIOCOAG PROBE
K092571 · KNS
Gyrus Acmi, Inc.
Gastroenterology & Urology · 425d
Cleared Jul 01, 2010
PK SUPERPULSE SYSEM GENERATOR MODEL 744000
K100816 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 100d
Cleared Jun 17, 2010
GYRUS ACMI HALO PKS CUTTING FORCEPS
K100896 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 78d