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
103441–103464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1995
LUHR(R) TITANIUM BURR HOLE COVERS
K950115 · HRS
Howmedica, Inc.
Orthopedic · 89d
Cleared Apr 10, 1995
UNIVIT PROBE
K950287 · HKP
Medical Instrument Development...
Ophthalmic · 76d
Cleared Apr 10, 1995
CARDON PHYSICAL THERAPY TABLES MODELS: R27622
K950873 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 41d
Cleared Apr 10, 1995
C&B-METABOND RADIOPAQUE POWDER
K950905 · KLE
Parkell, Inc.
Dental · 41d
Cleared Apr 10, 1995
COOPER LASER SONICS CUSA MODEL 200
K950945 · LFL
Valleylab, Inc.
General & Plastic Surgery · 82d
Cleared Apr 10, 1995
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
K951004 · KPY
Kenex , Ltd.
Radiology · 54d
Cleared Apr 10, 1995
SUN-BURST
K951120 · IOR
Kid'S Wheel-Chairs
Physical Medicine · 42d
Cleared Apr 10, 1995
FB-18X, FIBER BRONCHOSCOPE
K951199 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 25d
Cleared Apr 10, 1995
ALGI-BAND
K951237 · ELW
Health-Dent Intl., Inc.
Dental · 21d
Cleared Apr 10, 1995
CITATION SINUSCOPE
K951249 · EOB
Citation Medical Corp.
Ear, Nose, Throat · 21d
Cleared Apr 10, 1995
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K951265 · BSP
Sherwood Medical Co.
Anesthesiology · 20d
Cleared Apr 10, 1995
NEITZ SLIT LAMP SL-H1
K951340 · HJO
Neitz Instruments Company, Ltd.
Ophthalmic · 17d
Cleared Apr 10, 1995
SYMBIOSIS BIPOLAR SCISSORS
K951387 · GCJ
Symbiosis Corp.
General & Plastic Surgery · 14d
Cleared Apr 07, 1995
SIEMENS CLINICAL WORK STATION
K935043 · DQK
Siemens Medical Electronics
Cardiovascular · 533d
Cleared Apr 07, 1995
PRIME CEMENTED HIP SYSTEM
K940328 · JDI
Orthopaedic Innovations, Inc.
Orthopedic · 438d
Cleared Apr 07, 1995
GELFLEX
K940848 · LPL
Venture Management Corp.
Ophthalmic · 408d
Cleared Apr 07, 1995
DELTA
K943178 · LPL
Venture Management Corp.
Ophthalmic · 276d
Cleared Apr 07, 1995
AT-III CALIBRATOR
K944279 · JBQ
American Bioproducts Co.
Hematology · 220d
Cleared Apr 07, 1995
PENN-PET SCANNER
K945721 · KPS
Ugm Medical Systems, Inc.
Radiology · 137d
Cleared Apr 07, 1995
PRO-TEC-CASE
K950530 · LRX
Hyman, Phelps & McNamara, P.C.
Ophthalmic · 59d
Cleared Apr 07, 1995
MENICON SP VIAL
K950878 · LRX
Hyman, Phelps & McNamara, P.C.
Ophthalmic · 38d
Cleared Apr 07, 1995
FST CATH-UD, CATHETER
K950908 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 07, 1995
BIPOLAR FORCEPS
K951035 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 32d
Cleared Apr 07, 1995
ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K951180 · LPL
Szabocsik and Assoc.
Ophthalmic · 22d