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
108961–108984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1994
EZTEST-STEAM
K930682 · FRC
Sgm Biotech, Inc.
General Hospital · 418d
Cleared Apr 04, 1994
DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR
K934287 · IMG
Dynawave, Corp.
Physical Medicine · 214d
Cleared Apr 04, 1994
FLOW SPIROMETER
K934502 · BZH
Healthdyne, Inc.
Anesthesiology · 202d
Cleared Apr 04, 1994
HYDROCOLLOID HEATING UNIT
K935151 · ELW
Centrix, Inc.
Dental · 158d
Cleared Apr 04, 1994
TRANSFER SET
K935532 · LHI
Puritas Health Care, Inc.
General Hospital · 139d
Cleared Apr 04, 1994
BEHIND THE EAR HEARING AID
K936190 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 98d
Cleared Apr 04, 1994
WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM
K940056 · FPA
Puritas Health Care, Inc.
General Hospital · 89d
Cleared Apr 04, 1994
STOPCOCK INTRAVENOUS THERAPY
K940070 · FMG
Puritas Health Care, Inc.
General Hospital · 88d
Cleared Apr 04, 1994
AURIUM G14
K940930 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared Apr 01, 1994
EASIMIST ULTRASONIC NEBULIZER
K921273 · CAF
Medix Corp.
Anesthesiology · 745d
Cleared Apr 01, 1994
FUKUDA DENSHI MODEL HG-301
K921454 · DQA
Fukuda Denshi USA, Inc.
Anesthesiology · 736d
Cleared Apr 01, 1994
SCHUSTER DISPOSABLE BALLOON PROBE
K931175 · FAP
Sandhill Scientific, Inc.
Gastroenterology & Urology · 388d
Cleared Apr 01, 1994
MID LABS TWIN ILLUMINATOR
K932131 · EQH
Medical Instrument Development...
Ear, Nose, Throat · 333d
Cleared Apr 01, 1994
MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS
K932240 · IRR
Bailey Mfg. Co.
Physical Medicine · 329d
Cleared Apr 01, 1994
MICROINFUSOR
K932306 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 325d
Cleared Apr 01, 1994
GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE
K933173 · FAS
Greenwald Surgical Co., Inc.
Gastroenterology & Urology · 276d
Cleared Apr 01, 1994
GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
K933174 · FAS
Greenwald Surgical Co., Inc.
Gastroenterology & Urology · 276d
Cleared Apr 01, 1994
GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE
K933175 · FAS
Greenwald Surgical Co., Inc.
Gastroenterology & Urology · 276d
Cleared Apr 01, 1994
SUNGLASSES
K935099 · HQY
Taiwan Tong AI Co., Ltd.
Ophthalmic · 161d
Cleared Apr 01, 1994
OSHER SURGICAL GONIO/POSTERIOR POLE LENS
K935302 · HKS
Ocular Instruments, Inc.
Ophthalmic · 150d
Cleared Apr 01, 1994
SCMD KERATOME
K935342 · HNO
S.C.M.D. Keratomes of Arizona
Ophthalmic · 147d
Cleared Apr 01, 1994
ELECTROSURGICAL DEVICE, MODEL 26-2500
K935490 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 137d
Cleared Apr 01, 1994
7500 DATA TOWER
K935498 · LMB
E-Systems, Inc.
Radiology · 136d
Cleared Apr 01, 1994
MEGABEAM ENDOCULAR PROBE
K935747 · HQF
Ceram Optec, Inc.
Ophthalmic · 121d