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
156961–156984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1983
VENTREX ENZYME TSH KIT
K830928 · JLW
Ventrex Laboratories, Inc.
Chemistry · 36d
Cleared Apr 28, 1983
PREFILLED RESPIRATORY THERAPY VIAL
K830943 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 35d
Cleared Apr 28, 1983
MALE EXTERNAL CATHETER
K830946 · KNX
Post Medical, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 28, 1983
HELENA BIOSTRIP P
K830977 · JIR
Helena Laboratories
Chemistry · 30d
Cleared Apr 28, 1983
POCKET SPIROMETER
K830995 · BZK
P.K. Morgan Instruments, Inc.
Anesthesiology · 30d
Cleared Apr 28, 1983
ANDREWS REMOTE CHUCK DRILL
K831043 · HXY
Orthopedic Systems, Inc.
Orthopedic · 28d
Cleared Apr 28, 1983
DEFIBRILLATOR VPD 545
K831056 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 27d
Cleared Apr 28, 1983
P & T MEDIUM
K831059 · JSM
American Micro Scan
Pathology · 27d
Cleared Apr 28, 1983
OSCAR COLOR VISION TESTER
K831074 · HIT
Carl Zeiss, Inc.
Ophthalmic · 24d
Cleared Apr 28, 1983
COMPRESSION SYSTEM
K831076 · JDO
Kirschner Medical Corp.
Orthopedic · 24d
Cleared Apr 28, 1983
LIQUIPETTE
K831079 · GJG
The Kendall Company Div. of Tyco...
Hematology · 24d
Cleared Apr 28, 1983
MINI-VOL EXTENSION SET
K831087 · FPA
Beech Medical, Inc.
General Hospital · 24d
Cleared Apr 28, 1983
MINI-VOL I.V. SET
K831088 · FPA
Beech Medical, Inc.
General Hospital · 24d
Cleared Apr 28, 1983
INFUSION PUMP
K831089 · FLL
Beech Medical, Inc.
General Hospital · 24d
Cleared Apr 28, 1983
CURITY LEG BAG
K831121 · KNX
The Kendal Co.
Gastroenterology & Urology · 23d
Cleared Apr 28, 1983
PANASONIC MODEL HV-5
K831150 · FLL
Panasonic Co. Div. Matsu Elec. Corp....
General Hospital · 20d
Cleared Apr 28, 1983
I/A KIT
K831159 · JSM
Staar Surgical Co.
Microbiology · 17d
Cleared Apr 28, 1983
TOP-FILL BAG
K831169 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 17d
Cleared Apr 28, 1983
ULTRASOUND EQUIPMENT MODEL SDL-100A
K837084
Elscint, Inc.
Radiology · 93d
Cleared Apr 28, 1983
TRANSPARENT X-RAY COMPENSATION FILTER
K837245
Victoreen, Inc.
Radiology · 51d
Cleared Apr 27, 1983
PERSONAL ROMEAR
K823588 · ESD
Romear Mfg., Inc.
Ear, Nose, Throat · 142d
Cleared Apr 27, 1983
EK COMBI MSG-1
K830410 · DSP
Jedmed Instrument Co.
Cardiovascular · 78d
Cleared Apr 27, 1983
MINISCOPE MS-2
K830411 · DSP
Jedmed Instrument Co.
Cardiovascular · 78d
Cleared Apr 27, 1983
PHADEBACT STREP F TEST
K830445 · GTZ
Pharmacia, Inc.
Microbiology · 76d