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
171169–171192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1978
UM VII (BEHIND THE EAR)
K780922 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 9d
Cleared Jun 14, 1978
CT5137 HIGH RESOLUTION OPTION
K780928 · JAK
Emi Medical, Inc.
Radiology · 9d
Cleared Jun 14, 1978
5543 INDEPENDENT VIEWING SYSTEM
K780930 · JAK
Emi Medical, Inc.
Radiology · 8d
Cleared Jun 13, 1978
MILK BATH CONCENTRATE
K780258
Sparta Instrument Corp.
General & Plastic Surgery · 118d
Cleared Jun 13, 1978
FIBER OPTIC ADJUSTABLE HEADLIGHT
K780433 · FCT
Cameron-Miller, Inc.
Ophthalmic · 88d
Cleared Jun 13, 1978
HDL CHOLESTEROL
K780659 · CHH
Macomb Chemical Co.
Chemistry · 54d
Cleared Jun 13, 1978
SOLUTIONS FOR RESPIRATORY THERAPY
K780668 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 53d
Cleared Jun 13, 1978
TSH RIA KIT
K780726 · JLW
Amersham Corp.
Chemistry · 41d
Cleared Jun 13, 1978
URINARY CATHETER CARE SET
K780735 · FCM
Shield Laboratories, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 13, 1978
PERALISTIC PUMP MODEL 2000
K780789 · JQW
Innovative Medical Systems, Inc.
Chemistry · 29d
Cleared Jun 13, 1978
SGPT/ALT REAGENT SYSTEM
K780791 · CKA
American Monitor Corp.
Chemistry · 29d
Cleared Jun 13, 1978
TESTOSTERONE RADIOIMMUNOASSAY KIT 125I
K780792 · CDZ
The Upjohn Co.
Immunology · 29d
Cleared Jun 13, 1978
TRANSDUCER, PRESSURE, OPTION, H-P, P23ID
K780797 · DRS
Gould, Inc.
Cardiovascular · 29d
Cleared Jun 13, 1978
GOULD-STATHAM SP1405 PRESSURE MONITOR
K780798 · DSK
Gould, Inc.
Cardiovascular · 29d
Cleared Jun 13, 1978
VITAMIN B12 RADIOASSAY
K780799 · CDD
Amersham Corp.
Chemistry · 29d
Cleared Jun 13, 1978
ISOZYME - ID CPK MARKER
K780801 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 33d
Cleared Jun 13, 1978
ARMTROL AND FERMTROL
K780802 · JJW
Biotron , Ltd.
Chemistry · 33d
Cleared Jun 13, 1978
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812 · FFX
Honeywell, Inc.
Gastroenterology & Urology · 27d
Cleared Jun 13, 1978
URIC ACID RAPID STAT KIT
K780827 · KNK
Pierce Chemical Co.
Chemistry · 25d
Cleared Jun 13, 1978
NINHYDRIN REAGENT KIT
K780847 · JMX
Beckman Instruments, Inc.
Chemistry · 21d
Cleared Jun 13, 1978
MIXING BOWL & SPATULA, DISPOSABLE
K780857 · JDZ
Howmedica Corp.
Orthopedic · 20d
Cleared Jun 13, 1978
CAPP TERMINAL DEVICE
K780890 · IQX
Hosmer Dorrance Corp.
Physical Medicine · 13d
Cleared Jun 13, 1978
POST-OPERATIVE HIP ORTHOSIS
K780891 · ITS
Hosmer Dorrance Corp.
Physical Medicine · 13d
Cleared Jun 13, 1978
FRACTURE BRACING
K780892 · ITQ
Hosmer Dorrance Corp.
Physical Medicine · 13d