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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165961–165984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1980
CLIRANS TE15 HOLLOW FIBER DIALYZER
K801193 · KDJ
Terumo America, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 12, 1980
CLIRANS TE07 HOLLOW FIBER DIALYZER
K801194 · FJI
Terumo America, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 12, 1980
PERITONEAL DIALYSIS CYCLER SET W/PUMP
K801220 · KDJ
American Medical Products, Inc.
Gastroenterology & Urology · 82d
Cleared Aug 12, 1980
SILICAP
K801227 · EMA
Vivadent (Usa), Inc.
Dental · 81d
Cleared Aug 12, 1980
ACCU-PAP T ZONE SAMPLER
K801238 · HFC
Robert Hasselbrack, M.D.
Obstetrics & Gynecology · 77d
Cleared Aug 12, 1980
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA
K801346 · GIF
Nobel Scientific Industries, Inc.
Hematology · 64d
Cleared Aug 12, 1980
PAN-AM MYELOGRAM TRAY
K801431 · FMI
Waters Assoc., Inc.
Radiology · 55d
Cleared Aug 12, 1980
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
K801441 · FRN
Abbott Laboratories
General Hospital · 53d
Cleared Aug 12, 1980
FRAZIER-FERGUSON SUCTION TUBES
K801468 · KCB
Edward Weck, Inc.
Ear, Nose, Throat · 49d
Cleared Aug 12, 1980
HOLLISTER DRAINAGE POUCH
K801504 · FON
Hollister, Inc.
Gastroenterology & Urology · 46d
Cleared Aug 12, 1980
MCGRAW I.V. ADMINISTRATION SET
K801540 · FPA
American Hospital Supply Corp.
General Hospital · 40d
Cleared Aug 12, 1980
GLYCOSYLATED HEMOGLOBIN KIT
K801561 · LCP
Amersham Corp.
Hematology · 35d
Cleared Aug 12, 1980
BIMECO FILTERED EXTENSION SET
K801605 · FPB
Burron Medical Products, Inc.
General Hospital · 28d
Cleared Aug 12, 1980
MCCULLEY CONTINUOUS SUTURE TIGHTNER
K801608 · HND
Edward Weck, Inc.
Ophthalmic · 28d
Cleared Aug 12, 1980
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET
K801613 · FPA
Y
General Hospital · 28d
Cleared Aug 12, 1980
COVER-ALL MALE INCONTINENCE DEVICE
K801629 · KNX
The Urology Group
Gastroenterology & Urology · 28d
Cleared Aug 08, 1980
NSI WASH SOLUTION CONCENTRATE
K800587 · JJC
Nobel Scientific Industries, Inc.
Chemistry · 144d
Cleared Aug 07, 1980
MODEL H 607-.67M2 30 MICRON RP AN69 MEM
K800536 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 150d
Cleared Aug 07, 1980
NIKKISO PARALLEL FLOW DIALYZERS
K801065 · FTG
Int'L Marketing & Sales Corp.
General & Plastic Surgery · 93d
Cleared Aug 07, 1980
PALODENT MATRICES & BITINE RINGS
K801142 · DZN
Alvin Meyer, D.D.S.
Dental · 86d
Cleared Aug 07, 1980
LOSEFF BALLOON TYPE SELF-RETENTION WOUND
K801349 · JCX
Loseff Medical Designers, Ltd.
General & Plastic Surgery · 59d
Cleared Aug 07, 1980
KOLD WRAP
K801365 · IME
Romaine, Inc.
Physical Medicine · 58d
Cleared Aug 07, 1980
MOM 2
K801607 · CCL
Neotronics, Inc.
Anesthesiology · 23d
Cleared Aug 07, 1980
RESTRAINT, PROTECTIVE
K801628 · IQK
The Owenby Co.
Physical Medicine · 23d