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
124705–124728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1990
RSI FEMORAL GUIDING CATHETER
K902943 · DQO
Retroperfusion Systems, Inc.
Cardiovascular · 90d
Cleared Oct 03, 1990
DIMENSION-II TOTAL HIP SYSTEM
K902961 · JDI
Kirschner Medical Corp.
Orthopedic · 90d
Cleared Oct 03, 1990
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991 · GTY
Hybritech, Inc.
Microbiology · 86d
Cleared Oct 03, 1990
MODULAR CATHCART FRACTURE SYSTEM
K903084 · LZY
Depuy, Inc.
Orthopedic · 83d
Cleared Oct 03, 1990
AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE
K903694 · IYT
Amici, Inc.
Radiology · 49d
Cleared Oct 03, 1990
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
K903732 · FOZ
Kendall Healthcare Products Co....
General Hospital · 48d
Cleared Oct 03, 1990
PROTECTED NEEDLE WITH OR WITHOUT IV SET
K903809 · FPA
Kendall Mcgaw Laboratories, Inc.
General Hospital · 44d
Cleared Oct 03, 1990
IVAC(R) SYRINGE PUMP - MODEL 740
K903879 · FRN
Y
General Hospital · 42d
Cleared Oct 03, 1990
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
K903914 · JGQ
Baxter Healthcare Corp
Chemistry · 40d
Cleared Oct 03, 1990
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
K903942 · IZO
Shimadzu Medical Systems
Radiology · 37d
Cleared Oct 03, 1990
MODEL #527 OPHTHALMIC STRETCHER
K904011 · FPO
Midmark Corp.
General Hospital · 35d
Cleared Oct 03, 1990
POLYVIOLENE(TM) SUTURE
K904054 · GAS
Look, Inc.
General & Plastic Surgery · 64d
Cleared Oct 03, 1990
CIBA CORNING ACS HCG IMMUNOASSAY
K904123 · JHI
Ciba Corning Diagnostics Corp.
Chemistry · 27d
Cleared Oct 03, 1990
PRO-LOK (TM) EXTENSION SETS
K904217 · FPA
Vlv Associates, Inc.
General Hospital · 21d
Cleared Oct 03, 1990
KODAK X-MAT 270 RA PROCESSOR
K904238 · IXW
Eastman Kodak Company
Radiology · 19d
Cleared Oct 03, 1990
PS MEDICAL CRANIAL HAND DRILL
K904283 · HBG
Pudenz-Schulte Medical Research Corp.
Neurology · 16d
Cleared Oct 03, 1990
LATEX EXAMINATION GLOVE
K904324 · LYY
Gallimore Ent., Inc.
General Hospital · 19d
Cleared Oct 02, 1990
ENTERAL PUMP SET WITH ENTERAL SPIKE
K895142 · KNT
Delmed, Inc.
Gastroenterology & Urology · 412d
Cleared Oct 02, 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
K895329 · KNT
Delmed, Inc.
Gastroenterology & Urology · 397d
Cleared Oct 02, 1990
ENTERAL PUMP SET W/ENTERA-FLO SPIKE
K895650 · KNT
Delmed, Inc.
Gastroenterology & Urology · 377d
Cleared Oct 02, 1990
THE OPHTHIMUS SYSTEM
K896017 · DQK
Hightech Vision
Cardiovascular · 351d
Cleared Oct 02, 1990
MODEL IS102S ND:YAG SURGICAL LASER SYSTEM
K902133 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 145d
Cleared Oct 02, 1990
CATARRHALIS TEST STRIP
K902595 · JTO
Remel Co.
Microbiology · 112d
Cleared Oct 02, 1990
BLAKE MEDICAL BREATHING TUBE SUPPORT
K902604 · CBH
Blake Medical, Inc.
Anesthesiology · 112d