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"
505–528 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 02, 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371 · LJC
Abbott Laboratories
Microbiology · 57d
Cleared May 16, 1989
TDX BARBITURATES SERUM
K892650 · DIS
Abbott Laboratories
Chemistry · 34d
Cleared Apr 19, 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Apr 10, 1989
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
K890698 · CKA
Abbott Laboratories
Chemistry · 59d
Cleared Mar 27, 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · GHH
Abbott Laboratories
Hematology · 60d
Cleared Mar 24, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521 · CJE
Abbott Laboratories
Chemistry · 50d
Cleared Mar 24, 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · CEP
Abbott Laboratories
Chemistry · 51d
Cleared Mar 17, 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208 · GCX
Abbott Laboratories
General Hospital · 88d
Cleared Mar 09, 1989
IMX B2-MICROGLOBULIN
K890421 · JZG
Abbott Laboratories
Immunology · 42d
Cleared Feb 28, 1989
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141 · FPA
Abbott Laboratories
General Hospital · 151d
Cleared Feb 28, 1989
LIFECARE MICRO PUMP
K883796 · FRN
Abbott Laboratories
General Hospital · 174d
Cleared Feb 27, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540 · CGS
Abbott Laboratories
Chemistry · 24d
Cleared Feb 10, 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · CGJ
Abbott Laboratories
Chemistry · 28d
Cleared Dec 27, 1988
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821 · KHS
Abbott Laboratories
Chemistry · 40d
Cleared Dec 22, 1988
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · KNT
Abbott Laboratories
Gastroenterology & Urology · 71d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · LJC
Abbott Laboratories
Microbiology · 14d
Cleared Dec 16, 1988
TDX METHADONE ASSAY
K884968 · DJR
Abbott Laboratories
Toxicology · 16d
Cleared Dec 13, 1988
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · KRB
Abbott Laboratories
Cardiovascular · 61d
Cleared Dec 06, 1988
ABBOTT A-GENT LIPASE REAGENT
K884596 · CHI
Abbott Laboratories
Chemistry · 33d
Cleared Dec 02, 1988
VISION LYTE (TM) POTASSIUM
K884566 · CEM
Abbott Laboratories
Chemistry · 31d
Cleared Dec 02, 1988
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO
K884207 · DHA
Abbott Laboratories
Chemistry · 57d
Cleared Nov 29, 1988
ABBOTT IMX LH
K884138 · CEP
Abbott Laboratories
Chemistry · 60d
Cleared Nov 29, 1988
TDX BENZODIAZEPINES SERUM
K883730 · JXM
Abbott Laboratories
Toxicology · 90d
Cleared Oct 20, 1988
TDX AMPHETAMINE/METHAMPHETAMINE II
K883707 · DKZ
Abbott Laboratories
Chemistry · 51d