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"
793–816 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 31, 1991
FLEXIFLO STOMATE EXTENSION TUBE
K902623 · KNT
Abbott Laboratories
Gastroenterology & Urology · 231d
Cleared Jan 23, 1991
IMX FREE TRIIODOTHYRONINE
K905261 · CDP
Abbott Laboratories
Chemistry · 63d
Cleared Nov 27, 1990
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · KNT
Abbott Laboratories
Gastroenterology & Urology · 111d
Cleared Nov 20, 1990
LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS
K904541 · LDJ
Abbott Laboratories
Toxicology · 47d
Cleared Nov 19, 1990
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
K903325 · KNT
Abbott Laboratories
Gastroenterology & Urology · 117d
Cleared Oct 29, 1990
'TDXFLX ANALYZER
K904226 · LCQ
Abbott Laboratories
Chemistry · 46d
Cleared Oct 12, 1990
TDX FREE T3 CALCULATION
K903433 · CDP
Abbott Laboratories
Chemistry · 73d
Cleared Sep 25, 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · JHI
Abbott Laboratories
Chemistry · 64d
Cleared Sep 19, 1990
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · FRN
Abbott Laboratories
General Hospital · 111d
Cleared Sep 10, 1990
IMX FREE T4 CALCULATION
K903384 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
TDX FREE T4 CALCULATION
K903383 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188 · JGS
Abbott Laboratories
Chemistry · 53d
Cleared Sep 07, 1990
IMX FREE T3 CALCULATION
K903432 · CDP
Abbott Laboratories
Chemistry · 38d
Cleared Sep 07, 1990
ABBOTT IMX FREE T4
K902834 · CEC
Abbott Laboratories
Chemistry · 71d
Cleared Aug 27, 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · FRN
Abbott Laboratories
General Hospital · 208d
Cleared Aug 27, 1990
LIFECARE MODEL 4 PUMP
K900467 · FRN
Abbott Laboratories
General Hospital · 208d
Cleared Aug 23, 1990
IMX B12
K903218 · LIG
Abbott Laboratories
Chemistry · 31d
Cleared Aug 23, 1990
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · KZD
Abbott Laboratories
General Hospital · 162d
Cleared Aug 15, 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · FOZ
Abbott Laboratories
General Hospital · 224d
Cleared Aug 02, 1990
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
K901981 · LCX
Abbott Laboratories
Chemistry · 92d
Cleared Jul 27, 1990
IMX CMV IGG ANTIBODY ASSAY
K900474 · LFZ
Abbott Laboratories
Microbiology · 176d
Cleared Jul 27, 1990
IMX CMV IGM ANTIBODY ASSAY
K900473 · LFZ
Abbott Laboratories
Microbiology · 176d
Cleared Jul 16, 1990
ABBOTT LIFECARE 4100 PCA INFUSER
K895710 · FRN
Abbott Laboratories
General Hospital · 294d
Cleared Jul 12, 1990
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
K895709 · FRN
Abbott Laboratories
General Hospital · 290d