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
96577–96600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1996
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200,...
K962856 · KDQ
Deknatel, Inc.
General Hospital · 37d
Cleared Aug 27, 1996
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
K955880 · CIG
Diagnostic Chemicals , Ltd.
Chemistry · 243d
Cleared Aug 27, 1996
CPR TRACHEOTOMY CARE TRAY
K960205 · BTO
Custom Pack Reliability
Anesthesiology · 224d
Cleared Aug 27, 1996
POSTERIOR ANNULOPLASTY BAND (MODEL 607)
K960356 · KRH
The Heart Valve Div. Medtronic...
Cardiovascular · 215d
Cleared Aug 27, 1996
PHOENIX CRX VALVE
K960435 · JXG
Phoenix Biomedical Corp.
Neurology · 209d
Cleared Aug 27, 1996
IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25
K961587 · JMO
Diagnostic Chemicals , Ltd.
Chemistry · 125d
Cleared Aug 27, 1996
DEI MODEL 20 EEG
K961718 · HCC
Discovery Engineering Intl., Inc.
Neurology · 117d
Cleared Aug 27, 1996
CEDIA PROCAINAMIDE ASSAY
K962099 · LAR
Boehringer Mannheim Corp.
Toxicology · 90d
Cleared Aug 27, 1996
QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
K962117 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Aug 27, 1996
CARBOMEDICS HANDLE
K962154 · DTJ
Carbomedics, Inc.
Cardiovascular · 84d
Cleared Aug 27, 1996
KSEA BIPOLAR GOAGULATING FORCEPS
K962396 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 67d
Cleared Aug 27, 1996
STATAK SOFT TISSUE ATTACHMENT DEVICE
K962397 · MBI
Zimmer, Inc.
Orthopedic · 67d
Cleared Aug 27, 1996
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
K962472 · FAP
Rusch Intl.
Gastroenterology & Urology · 63d
Cleared Aug 27, 1996
KSEA UNIMAT PLUS
K962898 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 33d
Cleared Aug 27, 1996
AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY...
K962934 · HQD
Airperm, Inc.
Ophthalmic · 29d
Cleared Aug 27, 1996
ELECSYS CALCHECK FT3
K963163 · JJX
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 27, 1996
ELECSYS CALCHECK FT4
K963164 · JJX
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 27, 1996
ELECYS CALCHECK T 3
K963167 · JJX
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 27, 1996
ELECSYS CALCHECK T4
K963178 · JJX
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Aug 26, 1996
BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
K960424 · KWT
Endotec, Inc.
Orthopedic · 210d
Cleared Aug 26, 1996
LIGHT COMMANDER
K960767 · FCT
Scieran Technologies, Inc.
Ophthalmic · 182d
Cleared Aug 26, 1996
DYNATRON 125 ULTRASOUND
K961250 · IMI
Dynatronics Corp.
Physical Medicine · 147d
Cleared Aug 26, 1996
SALTER LABS 8990 SERIES NEBULIZER
K962085 · CAF
Salter Labs
Anesthesiology · 89d
Cleared Aug 26, 1996
HORIZON/WESTHIN 55-G
K962121 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 87d