FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79393–79416 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 61d
Cleared May 08, 2001
RANDOX MYOGLOBIN
K010700 · DDR
Randox Laboratories, Ltd.
Chemistry · 61d
Cleared May 08, 2001
MEDLINE STERISET STERILIZATION CONTAINER
K010825 · FRG
Medline
General Hospital · 50d
Cleared May 08, 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039 · FGE
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared May 08, 2001
QUICKVUE DIPSTICK STREP A
K011097 · GTY
Quidel Corp.
Microbiology · 27d
Cleared May 08, 2001
GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
K011120 · FPA
Nipro Diabetes Systems, Inc.
General Hospital · 26d
Cleared May 08, 2001
AQUARIUS WORKSTATION
K011142 · LLZ
Terarecon,Inc.
Radiology · 25d
Cleared May 08, 2001
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K011204 · OLV
Nihon Kohden America, Inc.
Neurology · 19d
Cleared May 08, 2001
EXHALE RF PROBE
K011267 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 12d
Cleared May 08, 2001
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
K011271 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 12d
Cleared May 07, 2001
ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
K003403 · JOS
Highland / Marietta, Inc.
General & Plastic Surgery · 187d
Cleared May 07, 2001
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS...
K003405 · KNF
Highland / Marietta, Inc.
Obstetrics & Gynecology · 187d
Cleared May 07, 2001
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
K010361 · GXR
Medtronic PS Medical
Neurology · 90d
Cleared May 07, 2001
D/C CORE MATERIAL
K010475 · EBF
Parkell, Inc.
Dental · 76d
Cleared May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · CGA
Instrumentation Laboratory CO
Chemistry · 74d
Cleared May 07, 2001
ACON STREP A RAPID TEST STRIP
K010582 · GTY
Acon Laboratories Co.
Microbiology · 69d
Cleared May 07, 2001
ATLAST DATA MANAGEMENT SOFTWARE (DMS)
K010605 · CGA
Amira Medical, Inc.
Chemistry · 68d
Cleared May 07, 2001
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
K010666 · QPB
Medtronic Xomed, Inc.
General & Plastic Surgery · 62d
Cleared May 07, 2001
XPS 3000 SYSTEM
K010677 · HRX
Medtronic Xomed, Inc.
Orthopedic · 61d
Cleared May 07, 2001
SIMPLICT
K010813 · JAK
Neorad AS
Radiology · 49d
Cleared May 04, 2001
TETRAD TC-C3-ACP
K002193 · ITX
Tetrad Corp.
Radiology · 288d
Cleared May 04, 2001
REMREST
K002763 · BZD
Medical Industries America, Inc.
Anesthesiology · 241d
Cleared May 04, 2001
MPS M ELECTRODE
K002801 · LNS
Medical Physics and Services, Inc.
Gastroenterology & Urology · 238d
Cleared May 04, 2001
RENAX A.V. FISTULA NEEDLE SETS
K003123 · FIE
Sunder Biomedical Tech. Co., Ltd.
Gastroenterology & Urology · 211d