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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
104233–104256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1995
PHOTOTHERAPEUTIX MODEL 800B
K933952 · FTC
Avex Industries , Ltd.
General & Plastic Surgery · 558d
Cleared Feb 21, 1995
PHOTOTHERAPEUTIX MODEL 1650B
K933953 · FTC
Avex Industries , Ltd.
General & Plastic Surgery · 558d
Cleared Feb 21, 1995
PHOTOTHERAPEUTIX MODEL 2400B
K933954 · FTC
Avex Industries , Ltd.
General & Plastic Surgery · 558d
Cleared Feb 21, 1995
DISPOSABLE ASPIRATION/IRRIGATION CATHETER
K934154 · GWG
Neuro Navigational Corp.
Neurology · 543d
Cleared Feb 21, 1995
503 MAXI COMPRESSOR
K940630 · BTI
Medical Industries America, Inc.
Anesthesiology · 372d
Cleared Feb 21, 1995
CUTANEOUS ELECTRODE
K941986 · GXY
Maxxim Medical
Neurology · 302d
Cleared Feb 21, 1995
SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
K942495 · KAM
Atos Medical AB
General & Plastic Surgery · 280d
Cleared Feb 21, 1995
CAPNOSAT
K942849 · CCK
Spegas Industries, Ltd.
Anesthesiology · 250d
Cleared Feb 21, 1995
SMD ELECTRODES
K943009 · GXY
Scientific Medical Devices, Inc.
Neurology · 242d
Cleared Feb 21, 1995
MODEL 6100 AMBULATORY INFUSION SYSTEM
K943310 · MEA
Pharmacia Deltec, Inc.
General Hospital · 225d
Cleared Feb 21, 1995
PACIFIER-THERMOMETER
K943362 · FLL
Questech Intl., Inc.
General Hospital · 223d
Cleared Feb 21, 1995
CPR MICROMASK
K943386 · CBP
Plasco, Inc.
Anesthesiology · 223d
Cleared Feb 21, 1995
KERRISON RONGEURS
K943583 · HAE
Enterprise Medical Corp.
Neurology · 214d
Cleared Feb 21, 1995
ULTIMAX (GREEN POWDER FREE EXAMINATION)
K943869 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 197d
Cleared Feb 21, 1995
ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES
K944487 · GXY
Prizm Medical, Inc.
Neurology · 161d
Cleared Feb 21, 1995
SCANNING DIRECTOR
K944585 · IQA
Prentke Romich Co.
Physical Medicine · 155d
Cleared Feb 21, 1995
KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES,...
K944861 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 141d
Cleared Feb 21, 1995
AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H
K945359 · BYD
Artema Medical AB
Anesthesiology · 111d
Cleared Feb 21, 1995
MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION
K945667 · KIC
Micos Medical Systems
Physical Medicine · 96d
Cleared Feb 21, 1995
A4722 OLYMPUS OPTICAL OBTURATOR
K950055 · HIH
Olympus America, Inc.
Obstetrics & Gynecology · 46d
Cleared Feb 21, 1995
4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050
K950392 · CBP
Cal West Trading Co.
Anesthesiology · 20d
Cleared Feb 21, 1995
SURGICAL SAW BLADES
K950403 · GFA
Transidyne General Corp.
General & Plastic Surgery · 21d
Cleared Feb 21, 1995
FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT
K950447 · BYD
Vital Signs, Inc.
Anesthesiology · 18d
Cleared Feb 17, 1995
THE HILL ADJUSTABLE AIR-FLEX MODEL
K932810 · JFB
Hill Laboratories Co.
Physical Medicine · 618d