FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134833–134856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1988
INFUSION HANDLE
K881518 · KYG
B&B Medical Assoc., Inc.
Ophthalmic · 133d
Cleared Aug 22, 1988
RETRACTIVE INCISION MICROMETER (RIM) GUAGE
K882402 · HNN
Optical Center
Ophthalmic · 73d
Cleared Aug 22, 1988
IOL IMPLANTATION FORCEPS
K883197 · HNR
D & D Surgical
Ophthalmic · 25d
Cleared Aug 22, 1988
EV MONOCANALICULAR STENT (TM)
K883233 · OKS
Eagle Vision, Inc.
Ophthalmic · 21d
Cleared Aug 19, 1988
3000 PHYSIOLOGICAL MONITOR
K880301 · DXG
Datascope Corp.
Cardiovascular · 207d
Cleared Aug 19, 1988
ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT
K880562 · DYH
Macrochem Corp.
Dental · 190d
Cleared Aug 19, 1988
COATING FOR WIRE GUIDE
K880722 · DQX
Cook, Inc.
Cardiovascular · 178d
Cleared Aug 19, 1988
TAPER-22 STEERABLE GUIDEWIRE
K880761 · DQX
Target Therapeutics
Cardiovascular · 176d
Cleared Aug 19, 1988
TAPER FLEX-TIP STEERABLE GUIDEWIRE
K880762 · DQX
Target Therapeutics
Cardiovascular · 176d
Cleared Aug 19, 1988
ECG MONITOR AND RESPIRATION PACER
K881055 · DPS
D. E. Hokanson, Inc.
Cardiovascular · 164d
Cleared Aug 19, 1988
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
K881663 · CCL
Salter Labs
Anesthesiology · 126d
Cleared Aug 19, 1988
RESPIRONIC'S INFANT SECUREEASY
K882079 · CBH
Respironics, Inc.
Anesthesiology · 94d
Cleared Aug 19, 1988
NIDEK US-3000
K882162 · IYO
Nidek, Inc.
Radiology · 88d
Cleared Aug 19, 1988
EXTERNAL PACEMAKER 2000 (EP2000)
K882168 · DRO
Unomed, Inc.
Cardiovascular · 87d
Cleared Aug 19, 1988
HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP
K882175 · JAA
Eigen
Radiology · 87d
Cleared Aug 19, 1988
LUHR MICRO SYSTEM
K882454 · HRS
Howmedica Corp.
Orthopedic · 66d
Cleared Aug 19, 1988
ATH METAL:UHMWPE TOTAL HIP SYSTEM
K882675 · KWA
Kinamed, Inc.
Orthopedic · 52d
Cleared Aug 19, 1988
THE BERG RESUSCITATION APPARATUS
K882833 · BTL
Hursch Ent., Inc.
Anesthesiology · 42d
Cleared Aug 19, 1988
MECHANICAL TABLES AND ACCESSORIES
K882900 · INW
Rifton
Physical Medicine · 39d
Cleared Aug 19, 1988
DENTASCAN
K882906 · JAK
Mpdi, Inc.
Radiology · 38d
Cleared Aug 19, 1988
MEDA ONE-STEP
K882943 · GZJ
Medical Electronic Assn.
Neurology · 39d
Cleared Aug 19, 1988
LARYNGOSCOPE BLADES
K883414 · CCW
Truphatek, Ltd.
Anesthesiology · 4d
Cleared Aug 18, 1988
THE VENUS SYSTEM
K880773 · GWL
Neuroscientific Corp.
Neurology · 174d
Cleared Aug 18, 1988
ENDOVAGINAL PROBE, SMS-510VA
K882959 · IYO
Toshiba Medical Systems
Radiology · 35d