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
158041–158064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1983
COHERENT FUNDUSL RETINAL CAMERA
K822908 · HKI
Coherent Medical Division
Ophthalmic · 97d
Cleared Jan 05, 1983
BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.
K823273 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 64d
Cleared Jan 05, 1983
OXYGEN CONSUMPTION MONITOR #OCM-0100
K823359 · DRY
Bentley Laboratories, Inc.
Cardiovascular · 61d
Cleared Jan 05, 1983
PROFESSIONAL MARK I BIOFEEDBACK SYS
K823381 · HCC
Srs Co.
Neurology · 54d
Cleared Jan 05, 1983
RESPIRATORY GAS ANALYZER
K823449 · CCL
Thoratec Laboratories Corp.
Anesthesiology · 54d
Cleared Jan 05, 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
K823490 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 05, 1983
STOCK #64091-PEDIATRIC OXYGEN MASK
K823532 · BYG
B & F Medical Products, Inc.
Anesthesiology · 37d
Cleared Jan 05, 1983
CORCATH H & B VASCULAR ACCESS CATHETER
K823553 · LJS
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 35d
Cleared Jan 05, 1983
ACOH WELLNESS TESTER
K823554 · EWO
Occupational Health, Inc.
Ear, Nose, Throat · 35d
Cleared Jan 05, 1983
MAGTARAK RESPIRATORY MONITOR & FLOW SENS
K823555 · BZK
Penlon, Inc.
Anesthesiology · 35d
Cleared Jan 05, 1983
OXYGEN CONCENTRATOR UCC-100
K823582 · CAW
Linde Div. Union Carbide Corp.
Anesthesiology · 30d
Cleared Jan 05, 1983
UNI-CELL
K823587 · GLQ
Medical Specialties Laboratories
Hematology · 30d
Cleared Jan 05, 1983
FRONING GUIDANCE SYSTEM #TX-8200
K823675 · HAW
Today'S Machining & Design, Inc.
Neurology · 29d
Cleared Jan 05, 1983
COAT-A-COUNT MORPHINE KIT & COMPONENTS
K823680 · DDE
Diagnostic Products Corp.
Chemistry · 29d
Cleared Jan 05, 1983
DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO
K823688 · JLW
Corning Medical & Scientific
Chemistry · 29d
Cleared Jan 05, 1983
PREP TYPE A EXTRACTION CARTRIDGE
K823697 · DJY
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 27d
Cleared Jan 05, 1983
HOSPAL BLOOD LINES
K823707 · KOC
Hospal Medical Corp.
Gastroenterology & Urology · 27d
Cleared Jan 05, 1983
AML (ANGLE MAGNIFYING LENS
K823719 · HKI
Nikon, Inc.
Ophthalmic · 26d
Cleared Jan 05, 1983
CARDF
K823731 · DTP
Shiley, Inc.
Cardiovascular · 26d
Cleared Jan 05, 1983
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC
K823740 · DKB
Syva Co.
Chemistry · 23d
Cleared Jan 05, 1983
24 CELL WELLS TISSUE CULTURE
K823747 · KJG
Corning Medical & Scientific
Pathology · 23d
Cleared Jan 03, 1983
ARGON FIBER OPTIC CATHETER
K827847
Hgm, Inc.
Radiology · 60d
Cleared Jan 03, 1983
COMPUTER DATA MONITORING SYSTEM
K828564
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Jan 03, 1983
BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS
K828565
Medical Electronics Corp.
Radiology · 75d