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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
649–672 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 23, 1995
IMX FOLATE
K943691 · CGN
Abbott Mfg., Inc.
Chemistry · 237d
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 12, 1994
FLEXIFLO SIX ENTERAL NUTRITION PUMP
K943733 · LZH
Abbott Mfg., Inc.
General Hospital · 132d
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 Oct 03, 1994
LIFESHIELD EXTENSION SET
K941214 · FPK
Abbott Mfg., Inc.
General Hospital · 207d
Cleared Sep 22, 1994
CARDIAC CATHETERIZATION KIT
K932141 · DQO
Abbott Laboratories
Cardiovascular · 518d
Cleared Aug 18, 1994
AXSYM TOBRAMYCIN
K941614 · LFW
Abbott Laboratories
Toxicology · 136d
Cleared Aug 16, 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · JLW
Abbott Laboratories
Chemistry · 77d
Cleared Aug 16, 1994
AXSYM VALPROIC ACID
K941615 · LEG
Abbott Laboratories
Toxicology · 134d
Cleared Aug 03, 1994
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · FPB
Abbott Laboratories
General Hospital · 121d