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

Filters: Cleared only ×
174,955 results
97945–97968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1996
INTEGRATOR
K950646 · LXM
Moyco Union Broach, Div., Moyco...
Physical Medicine · 442d
Cleared Apr 30, 1996
BRAUN HEMODIALYSIS BLOOD CIRCUITS
K952631 · FJK
B.Braun Medical, Inc.
Gastroenterology & Urology · 327d
Cleared Apr 30, 1996
V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER
K953300 · LJS
Hdc Corp.
General Hospital · 291d
Cleared Apr 30, 1996
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
K954158 · KQO
Solarcare Technologies Corp,Inc.
Chemistry · 238d
Cleared Apr 30, 1996
ARCO-MBC, ARCO MC
K954171 · GEI
Holl Meditronics, Inc.
General & Plastic Surgery · 238d
Cleared Apr 30, 1996
EMOX
K954506 · CAW
Medtrak Intl., Inc.
Anesthesiology · 215d
Cleared Apr 30, 1996
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
K954570 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 211d
Cleared Apr 30, 1996
OLYMPUS KD SERIES SPHINCTEROTOME
K955247 · KNS
Olympus America, Inc.
Gastroenterology & Urology · 167d
Cleared Apr 30, 1996
MAYFIELD-ACCISS WORKSTATION
K955397 · HAW
Nomos Corp.
Neurology · 158d
Cleared Apr 30, 1996
MINIMED INFUSION PUMP, MODEL MMT-507
K960001 · LZG
Medtronic Minimed
General Hospital · 119d
Cleared Apr 30, 1996
SECURE EVA DUAL CHAMBER MIXING BAG
K960581 · KPE
Secure Medical Products, Inc.
General Hospital · 78d
Cleared Apr 30, 1996
GE ADVANTAGE WINDOWS REVIEW WORKSTATION
K960613 · LLZ
GE Medical Systems
Radiology · 77d
Cleared Apr 30, 1996
ZOMED 30F ELECTROSURGICAL PROBE
K960694 · GEI
Zomed Intl.
General & Plastic Surgery · 70d
Cleared Apr 30, 1996
MODEL 200C ELECTROSURGICAL PROBE
K960695 · GEI
Zomed Intl.
General & Plastic Surgery · 70d
Cleared Apr 30, 1996
LM ANCHOR OR OTHER PROPRIETARY NAME
K960825 · MBI
Li Medical Technologies, Inc.
Orthopedic · 61d
Cleared Apr 30, 1996
LIGHTSOURCE OR ILLUMINATOR
K961074 · FSS
Cuda Products Co.
General & Plastic Surgery · 43d
Cleared Apr 30, 1996
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
K961135 · DYB
C.R. Bard, Inc.
Cardiovascular · 40d
Cleared Apr 30, 1996
DAUM BIOPSYNEEDLE
K961185 · FCG
Ferguson Medical
Gastroenterology & Urology · 35d
Cleared Apr 30, 1996
TONOMETERED SLAINE BLOOD GAS CONTROL
K961441 · JJS
Instrumentarium Corp.
Chemistry · 15d
Cleared Apr 29, 1996
AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE
K943145 · HQY
The Monticello Group, Inc.
Ophthalmic · 669d
Cleared Apr 29, 1996
EBNA IGG EIA TEST SYSTEM
K951549 · LLM
Immunoprobe, Inc.
Microbiology · 391d
Cleared Apr 29, 1996
RAILWIRE
K954552 · DQX
Boston Scientific /International...
Cardiovascular · 210d
Cleared Apr 29, 1996
IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK
K954622 · DQX
Boston Scientific /International...
Cardiovascular · 207d
Cleared Apr 29, 1996
PEDI VAGINAL ASPIRATOR
K954903 · HFC
Cook Urological, Inc.
Obstetrics & Gynecology · 187d