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
113833–113856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1993
CURITY PLASTIC LOSS OF RESISTANCE SYRINGE
K922162 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 335d
Cleared Apr 07, 1993
CONBIO-MEDLITE(TM) Q-SWITCHED ND:YAG LASER SYSTEM
K922577 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 310d
Cleared Apr 07, 1993
CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
K922935 · GEX
Buckman Co., Inc.
General & Plastic Surgery · 293d
Cleared Apr 07, 1993
PORT-XP
K923359 · IZL
Mobile Dental Equipment Corp.
Radiology · 273d
Cleared Apr 07, 1993
MAGIC INFUSION CATHETER
K923368 · KRA
Target Therapeutics
Cardiovascular · 272d
Cleared Apr 07, 1993
LECTRO-LARYNX
K923648 · ESE
Bruce Medical Supply
Ear, Nose, Throat · 260d
Cleared Apr 07, 1993
O.R. CONCEPTS' IRRIGATING KITTNER
K923818 · FGS
O.R. Concepts, Inc.
Gastroenterology & Urology · 251d
Cleared Apr 07, 1993
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · FRN
Abbott Laboratories
General Hospital · 259d
Cleared Apr 07, 1993
ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE
K924035 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 239d
Cleared Apr 07, 1993
MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTS
K924283 · GEI
Microsurge, Inc.
General & Plastic Surgery · 225d
Cleared Apr 07, 1993
PERSONAL DISPLAY SYSTEM
K924366 · LLZ
Vortech Data, Inc.
Radiology · 222d
Cleared Apr 07, 1993
BARD(R) INTRA AORTIC BALLOON
K924382 · DSP
C.R. Bard, Inc.
Cardiovascular · 219d
Cleared Apr 07, 1993
GRASPERS & SCISSORS (MINIMAL ACCESS SURG INSTR)
K924469 · GEI
Conmedcorp
General & Plastic Surgery · 217d
Cleared Apr 07, 1993
LPI ML210 HOLMIUM SURGICAL LASER
K924537 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 215d
Cleared Apr 07, 1993
XTEND CIRCUITS (TM)
K924627 · CAI
Arc Medical, Inc.
Anesthesiology · 205d
Cleared Apr 07, 1993
SURGICAD(TM) VIEW(TM)
K924630 · LLZ
Surgicad Corp.
Radiology · 205d
Cleared Apr 07, 1993
LCM-2-LINAC COUCH-MOUNT SYSTEM
K924632 · IYE
Radionics, Inc.
Radiology · 205d
Cleared Apr 07, 1993
CLARUS ENDOSCOPIC BALL PROBE
K926048 · GZX
Clarus Medical Systems, Inc.
Neurology · 127d
Cleared Apr 07, 1993
DMI LAPAROSCOPIC ELECTRODES
K926079 · GCJ
Diversified Medical Instruments, Inc.
General & Plastic Surgery · 127d
Cleared Apr 07, 1993
SOYEE ALUMINUM INTERSPACED X-RAY GRID
K926445 · IXJ
X-Ray Accessories Mfg. Co.
Radiology · 105d
Cleared Apr 07, 1993
ENDOGRIP
K926498 · BTR
Biomedix, Inc.
Anesthesiology · 99d
Cleared Apr 07, 1993
CORDIS REFLEX STEERABLE GUIDEWIRE
K930091 · DQX
Cordis Corp.
Cardiovascular · 89d
Cleared Apr 07, 1993
OPTICON(TM) CONNECTOR ADAPTER
K930159 · GEX
Xintec Corporation
General & Plastic Surgery · 84d
Cleared Apr 07, 1993
JPI X-RAY FILM CASSETTE
K930244 · IXA
Jpi, Inc.
Radiology · 78d