FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126673–126696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
K895330 · KNT
Delmed, Inc.
Gastroenterology & Urology · 244d
Cleared May 02, 1990
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
K895366 · KNT
Fresenius USA, Inc.
Gastroenterology & Urology · 247d
Cleared May 02, 1990
ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU
K895696 · KNT
Delmed, Inc.
Gastroenterology & Urology · 223d
Cleared May 02, 1990
ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
K895919 · KNT
Delmed, Inc.
Gastroenterology & Urology · 204d
Cleared May 02, 1990
ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III
K895933 · KNT
Delmed, Inc.
Gastroenterology & Urology · 204d
Cleared May 02, 1990
MD2 PERSONAL INFUSION SYSTEM
K896544 · FRN
Norfolk Medical Products, Inc.
General Hospital · 166d
Cleared May 02, 1990
URINE COLLECTOR LEG BAG
K896688 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 155d
Cleared May 02, 1990
DYNA-FLO URINARY DRAINAGE BAG
K896695 · EYZ
Medline Industries, Inc.
Gastroenterology & Urology · 155d
Cleared May 02, 1990
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853 · KWL
Howmedica Corp.
Orthopedic · 148d
Cleared May 02, 1990
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K897078 · LQF
Gen-Probe, Inc.
Microbiology · 131d
Cleared May 02, 1990
OPERAND* LUBRICATING JELLY
K900110 · KMJ
General Medical Co.
General Hospital · 113d
Cleared May 02, 1990
LYME IGM ELISA TEST SYSTEM
K900196 · LSR
Zeus Scientific, Inc.
Microbiology · 106d
Cleared May 02, 1990
ENZYMUN TEST(R) CORTISOL
K900485 · CGR
Boehringer Mannheim Corp.
Chemistry · 90d
Cleared May 02, 1990
INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.
K900555 · ITX
Interson Corp.
Radiology · 85d
Cleared May 02, 1990
RESPONSE EXTERNAL PENILE RIGIDITY DEVICE
K900559 · LKY
Smith-Collins Pharmaceutical, Inc.
Gastroenterology & Urology · 84d
Cleared May 02, 1990
LYME IGM MICROASSAY
K900572 · LSR
Diamedix Corp.
Microbiology · 84d
Cleared May 02, 1990
MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
K900735 · FMZ
Preemicare Corp.
General Hospital · 75d
Cleared May 02, 1990
CMV IGG ELISA TEST
K900796 · LFZ
Gull Laboratories, Inc.
Microbiology · 71d
Cleared May 02, 1990
COLORIMETRIC CHLORIDE PRODUCT #4314125
K900827 · CHI
American Research Products Co.
Chemistry · 70d
Cleared May 02, 1990
MAGNET RETRIEVAL CATHETER
K900852 · KNT
Cook, Inc.
Gastroenterology & Urology · 69d
Cleared May 02, 1990
MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
K900892 · KPS
Siemens Gammasonics, Inc.
Radiology · 64d
Cleared May 02, 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN
K901270 · DIF
Bio-Rad
Toxicology · 44d
Cleared May 02, 1990
EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP
K901297 · JDI
Exactech, Inc.
Orthopedic · 43d
Cleared May 02, 1990
THROMBOPLASTIN.C PLUS
K901325 · GJS
Baxter Healthcare Corp
Hematology · 42d