Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
155857–155880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1983
PHOENIX 60/60 PROCESSOR MODULE
K831134 · DSF
Phoenix Corp.
Cardiovascular · 214d
Cleared Nov 07, 1983
DINAMAP VITAL SIGNS MONITOR #1846P
K832656 · DXN
Critikon Company, LLC
Cardiovascular · 91d
Cleared Nov 07, 1983
DISPOSABLE MANIFOLD SET
K832657 · DRS
Mallinckrodt Critical Care
Cardiovascular · 91d
Cleared Nov 07, 1983
ARRHYTHMIA III CARDULE #1919
K832693 · DSI
Spacelabs, Inc.
Cardiovascular · 89d
Cleared Nov 07, 1983
BACK MASSAGER B-400 ADJUSTABLE
K832913 · ISA
Pollenex Associated Mills, Inc.
Physical Medicine · 70d
Cleared Nov 07, 1983
INTERMITTENT COMPRESSION PUMPS
K832920 · IRP
Chattanooga Group, Inc.
Physical Medicine · 77d
Cleared Nov 07, 1983
ROTAGYM
K832940 · ISD
I-Rep, Inc.
Physical Medicine · 70d
Cleared Nov 07, 1983
TOTAL & DIRECT BILIRUBIN PROCEDURES
K832942 · CIG
Sandare Chemical Co., Inc.
Chemistry · 69d
Cleared Nov 07, 1983
STIFNICK IMMOBILIZING COLLAR
K832990 · IQK
Laerdal California, Inc.
Physical Medicine · 67d
Cleared Nov 07, 1983
INFUSION SET-52-05-1 20 DROPS-MI VOL
K833033 · FPA
Y
General Hospital · 61d
Cleared Nov 07, 1983
UNIVERSAL VENTED & NON/VOLUME INFUS-
K833034 · FPA
Y
General Hospital · 61d
Cleared Nov 07, 1983
FLOW-PAC SODIUM REAGENT SET
K833036 · JGS
American Research Products Co.
Chemistry · 61d
Cleared Nov 07, 1983
C-FLEX PENROSE DRAINAGE TUBE
K833061 · FFA
Concept, Inc.
Gastroenterology & Urology · 59d
Cleared Nov 07, 1983
TDX GLUCOSE
K833069 · CGA
Abbott Laboratories
Toxicology · 60d
Cleared Nov 07, 1983
CASTLE TEC-TEST S.M.A.R.T. PACK
K833074 · JOJ
Castle Co.
General Hospital · 59d
Cleared Nov 07, 1983
SPIRIT CHEMISTRY SYSTEM
K833116 · JJE
Baker Instructions Corp.
Chemistry · 55d
Cleared Nov 07, 1983
FITNESS
K833249 · ION
Fitness Equipment Co., Inc.
Physical Medicine · 45d
Cleared Nov 07, 1983
BRUCELLA AGAR MODIFIED
K833299 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 46d
Cleared Nov 07, 1983
SABOURAUD BHI AGAR
K833300 · JSC
Acumedia Manufacturers, Inc.
Microbiology · 46d
Cleared Nov 07, 1983
AUTO-LANCET
K833344 · FMK
Palco Laboratories, Inc.
General & Plastic Surgery · 41d
Cleared Nov 07, 1983
MONOSPHERICAL RESURFACING GLENOID PROS
K833409 · KWT
Howmedica Corp.
Orthopedic · 38d
Cleared Nov 07, 1983
MONOSPHERICAL GLENOID PROSTH. KEEL
K833410 · KWS
Howmedica Corp.
Orthopedic · 38d
Cleared Nov 07, 1983
PACEMAKER EVALUATION MODULE-330
K833470 · DPS
Marquette Electronics, Inc.
Cardiovascular · 32d
Cleared Nov 07, 1983
PREPARED MACCONKEY AGAR
K833508 · JSI
Lavco Laboratory, Inc.
Microbiology · 27d