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
150433–150456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1984
SERACON TM SR III
K844027 · JIX
Bhp Diagnostix, Inc.
Chemistry · 43d
Cleared Nov 27, 1984
MOBILIMB HAND UNIT
K844033 · JFA
Danninger Medical Technology, Inc.
Physical Medicine · 43d
Cleared Nov 27, 1984
US 610
K844036 · IMI
Rich-Mar Corp.
Physical Medicine · 42d
Cleared Nov 27, 1984
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
K844044 · CEM
Medica Corp.
Chemistry · 41d
Cleared Nov 27, 1984
ENI BLOOD UREA NITROGEN REAGENT
K844065 · CDQ
Electro-Nucleonics Laboratories, Inc.
Chemistry · 40d
Cleared Nov 27, 1984
TDX SALICYLATE
K844070 · DKJ
Abbott Laboratories
Chemistry · 40d
Cleared Nov 27, 1984
WET DRESSING WATER-STERILE
K844095 · NAD
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 35d
Cleared Nov 27, 1984
PHARMACIA STREP A DIRECT SWAB TEST
K844107 · GTZ
Pharmacia, Inc.
Microbiology · 35d
Cleared Nov 27, 1984
ADD-1
K844114 · JJE
Abbott Laboratories
Chemistry · 35d
Cleared Nov 27, 1984
ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT
K844167 · DKP
Bd Becton Dickinson Vacutainer...
Toxicology · 33d
Cleared Nov 27, 1984
ACTH RIA
K844181 · CKG
Syncor Intl. Corp.
Chemistry · 32d
Cleared Nov 27, 1984
BIOTIS ANAEROBIC KBE AGAR
K844195 · JSI
Otisville Biotech, Inc.
Microbiology · 28d
Cleared Nov 27, 1984
MOSS LIMB LOAD MONITOR LM101-1
K844202 · IKE
Moss Rehabilation Hospital
Physical Medicine · 28d
Cleared Nov 27, 1984
RICH-MAR DELTA 330 HV
K844217 · IMG
Rich-Mar Corp.
Physical Medicine · 27d
Cleared Nov 27, 1984
RHINOMANOMETER A440 DIGITAL
K844230 · BXQ
Center Laboratories, Inc.
Anesthesiology · 26d
Cleared Nov 27, 1984
SGPT REAGENT SET
K844283 · CKD
Livonia Diagnostics, Inc.
Chemistry · 22d
Cleared Nov 27, 1984
CUSTOM LITE
K844321 · HQG
Buchmann Optical Industries
Ophthalmic · 21d
Cleared Nov 27, 1984
SGOT REAGENT SET
K844322 · CIQ
Livonia Diagnostics, Inc.
Chemistry · 20d
Cleared Nov 23, 1984
BONE STAPLING FIXATION SYS
K840566 · JDR
3M Company
Orthopedic · 289d
Cleared Nov 23, 1984
PHARMA-PLAST SUCTION SET TYPE YANKAUER
K843468 · GEA
Zimmar Consulting , Ltd.
General & Plastic Surgery · 78d
Cleared Nov 23, 1984
PDB II VIBRATING DRAINAGE BED
K843572 · JFB
Invacare Corp.
Physical Medicine · 73d
Cleared Nov 23, 1984
HEALTH PULSE FA-222 POWER MUSCLE STIMUL
K843638 · IPF
Therapeutic Equipment Corp.
Physical Medicine · 67d
Cleared Nov 23, 1984
KARECO INT'L WHEELCHAIR
K843688 · IOR
Kareco Intl., Inc.
Physical Medicine · 65d
Cleared Nov 23, 1984
ISOSTATION ANKLE/SUBTALAR MACHINE A-100
K844060 · IKK
Isotechnologies, Inc.
Physical Medicine · 36d