Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

901 results for "Abbott Laboratories"
313–336 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 23, 1995
LIFECARE 175 INFUSER, MODIFICATION
K944190 · FRN
Abbott Laboratories
General Hospital · 309d
Cleared May 18, 1995
AXSYM OPIATES
K951287 · DJG
Abbott Laboratories
Toxicology · 58d
Cleared May 18, 1995
AXSYM BARBITURATES II U
K951253 · DIS
Abbott Laboratories
Toxicology · 58d
Cleared May 17, 1995
IMX ESTRADIOL
K951629 · JIS
Abbott Laboratories
Chemistry · 61d
Cleared May 16, 1995
AXSYM CANNABINOIDS
K951288 · JXM
Abbott Laboratories
Toxicology · 56d
Cleared May 16, 1995
AXSYM BENZODIAZEPINES
K951286 · JXM
Abbott Laboratories
Toxicology · 56d
Cleared May 16, 1995
ABBOTT AXSYM II SYSTEM
K950915 · JJE
Abbott Laboratories
Toxicology · 76d
Cleared May 02, 1995
TDX(R)/TDXFLX(R) FREE PHENYTOIN II
K950280 · MOJ
Abbott Laboratories
Toxicology · 98d
Cleared Apr 27, 1995
IMX(R) TOXO IGM
K945634 · LGD
Abbott Laboratories
Microbiology · 162d
Cleared Apr 13, 1995
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
K943240 · KNT
Abbott Laboratories
Gastroenterology & Urology · 281d
Cleared Mar 28, 1995
TDX(R)/TDXFLX(R) PHENYTOIN II
K946328 · LGR
Abbott Laboratories
Toxicology · 89d
Cleared Mar 01, 1995
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · KNT
Abbott Laboratories
Gastroenterology & Urology · 1023d
Cleared Feb 08, 1995
PLUM XL INFUSION PUMP
K944733 · FRN
Abbott Laboratories
General Hospital · 135d
Cleared Feb 08, 1995
TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II
K940817 · JHF
Abbott Laboratories
Chemistry · 351d
Cleared Jan 09, 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · KNT
Abbott Laboratories
Gastroenterology & Urology · 972d
Cleared Dec 19, 1994
ABBOTT IMX 2 ANALYZER
K944731 · JJI
Abbott Laboratories
Toxicology · 98d
Cleared Dec 19, 1994
AXSYM DIGOXIN
K944506 · KXT
Abbott Laboratories
Microbiology · 96d
Cleared Dec 19, 1994
ABBOTT CHAGAS ANTIBODY EIA
K933716 · MIU
Abbott Laboratories
Microbiology · 507d
Cleared Dec 19, 1994
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · LFX
Abbott Laboratories
Microbiology · 658d
Cleared Dec 13, 1994
HIGH PRESSURE TUBING
K941978 · DQO
Abbott Laboratories
Cardiovascular · 243d
Cleared Dec 06, 1994
ABBOTT LTE INFUSION PUMP
K944125 · FRN
Abbott Laboratories
General Hospital · 105d
Cleared Nov 14, 1994
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED
K944202 · JGJ
Abbott Laboratories
Chemistry · 95d
Cleared Nov 14, 1994
CONTINUOUS CARDIAC OUTPUT SYSTEM
K932414 · DXG
Abbott Laboratories
Cardiovascular · 544d
Cleared Sep 22, 1994
CARDIAC CATHETERIZATION KIT
K932141 · DQO
Abbott Laboratories
Cardiovascular · 518d