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
88201–88224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1998
DEPUY MOTECH PEAK FIXATION SYSTEM
K982483 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 59d
Cleared Sep 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS
K982511 · KWP
Depuy, Inc.
Orthopedic · 56d
Cleared Sep 14, 1998
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL
K982601 · HSB
Osteonics Corp.
Orthopedic · 49d
Cleared Sep 14, 1998
RETROGRADE ROD SYSTEM
K982602 · HSB
Howmedica Corp.
Orthopedic · 49d
Cleared Sep 14, 1998
DORNIER MEDILAS D
K982629 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 48d
Cleared Sep 14, 1998
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE...
K982742 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 39d
Cleared Sep 14, 1998
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL...
K982743 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 39d
Cleared Sep 14, 1998
MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1
K982746 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 39d
Cleared Sep 14, 1998
MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2
K982749 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 39d
Cleared Sep 14, 1998
DERMA K ER:YAG/CO2 LASER
K982827 · GEX
Esc Medical Systems, Inc.
General & Plastic Surgery · 34d
Cleared Sep 14, 1998
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO...
K982884 · GEI
New Deantronics, Ltd.
General & Plastic Surgery · 28d
Cleared Sep 14, 1998
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
K983019 · KHS
Diagnostic Chemicals , Ltd.
Chemistry · 14d
Cleared Sep 14, 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
K983127 · DIF
Medical Analysis Systems, Inc.
Toxicology · 6d
Cleared Sep 11, 1998
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)
K980578 · DYB
Innerdyne, Inc.
Cardiovascular · 206d
Cleared Sep 11, 1998
FOAM TIP INJECTOR
K980696 · MSS
Staar Surgical Co.
Ophthalmic · 200d
Cleared Sep 11, 1998
LACTATE PRO SYSTEM
K980908 · KHP
Kdk Corp.
Chemistry · 185d
Cleared Sep 11, 1998
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K982083 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Sep 11, 1998
ULMER (VNG) VIDEO NYSTAGMOGRAPH
K982103 · GWN
Synapsys, Inc.
Neurology · 88d
Cleared Sep 11, 1998
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
K982216 · BZQ
Braebon Medical Corp.
Anesthesiology · 80d
Cleared Sep 11, 1998
KELLER PULSE OXIMETER, MODEL 850+
K982331 · DQA
Keller Medical Specialties Products,...
Anesthesiology · 71d
Cleared Sep 11, 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529 · MRR
Randox Laboratories, Ltd.
Chemistry · 53d
Cleared Sep 11, 1998
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT...
K982744 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 36d
Cleared Sep 11, 1998
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
K982894 · KNT
Ballard Medical Products
Gastroenterology & Urology · 25d
Cleared Sep 10, 1998
CETYLCIDE-G
K974188 · MED
Kellerandheckman
General Hospital · 307d