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
159001–159024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1982
GUIDE WIRE
K822597 · DQX
Vertex Medical Corp.
Cardiovascular · 25d
Cleared Sep 21, 1982
BLOOD PRESSURE MONITORING DEVICES
K822614 · DXN
Allied Healthcare Products, Inc.
Cardiovascular · 22d
Cleared Sep 21, 1982
LIFE WATCH LSI
K822615 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 22d
Cleared Sep 21, 1982
RIWOLITH 2135
K822644 · FFK
R. Wolf Medical Instruments Corp.
Gastroenterology & Urology · 20d
Cleared Sep 21, 1982
YERSINIA AGAR BASE & SUPPLEMENT
K822659 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
VOGEL JOHNSON AGAR
K822660 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
RAPID REAGIN CARD TEST
K822661 · GMQ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
REAGIN ANTIGEN SUSPENSION
K822662 · GMQ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
FEBRILE ANTIGEN KIT
K822663 · GSO
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
PSEUDOMONAS AGAR BASE, C-N & C-F-C SUPP
K822664 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
WILKINS-CHALGREN ANAEROBE BROTH
K822665 · JSC
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY
K822685 · BTI
Certified Respiratory Services, Inc.
Anesthesiology · 18d
Cleared Sep 21, 1982
DENVER PERITONEO-VENOUS SHUNT (DP-VS)
K822686 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 18d
Cleared Sep 21, 1982
ACU-MASSAGE TABLE
K822693 · JFB
H.W.E., Inc.
Physical Medicine · 14d
Cleared Sep 17, 1982
ENT MALLETS
K822204 · GFJ
Kelleher Corp.
General & Plastic Surgery · 56d
Cleared Sep 17, 1982
COMPLY NEUROMUSCULAR STIMULATOR
K822284 · IPF
Omega-Med Intl., Inc.
Physical Medicine · 49d
Cleared Sep 17, 1982
ROMBEAU GASTROSTOMY-JEJUNAL TUBE
K822380 · KNT
Hedeco
Gastroenterology & Urology · 39d
Cleared Sep 17, 1982
CREST PRESSURE INFUSOR
K822434 · KZD
Crest Medical Equipment
General Hospital · 35d
Cleared Sep 17, 1982
CALCIUM STANDARD, ITEM #65075
K822473 · JIS
Emd Chemicals, Inc.
Chemistry · 31d
Cleared Sep 17, 1982
CREATININE STANDARD #65072
K822477 · JIS
Emd Chemicals, Inc.
Chemistry · 31d
Cleared Sep 17, 1982
MULTIPLE SURGICAL MASK
K822481 · FXX
Surgilite Intl., Inc.
General Hospital · 31d
Cleared Sep 17, 1982
MULTIPLE SCRUB SUIT
K822483 · FXO
Surgilite Intl., Inc.
General Hospital · 31d
Cleared Sep 17, 1982
DISPOSABLE GRASPING FORCEPS
K822491 · GEN
Van-Tec, Inc.
General & Plastic Surgery · 30d
Cleared Sep 17, 1982
OPTIMIZED UV-LDH REAGENT SET
K822492 · CFJ
Biorent Diagnostic, Inc.
Chemistry · 30d