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
103297–103320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1995
HPRH HOSPITAL PATIENT RADIANT HEATER
K934262 · ILO
Marley Electric Heating Co.
Physical Medicine · 595d
Cleared Apr 18, 1995
STERIGAGE EO 100%
K934874 · JOJ
Pymah Corp.
General Hospital · 553d
Cleared Apr 18, 1995
DIGENE DCR-1 LUMINOMETER
K940486 · JJQ
Digene Diagnostics, Inc.
Microbiology · 440d
Cleared Apr 18, 1995
NONE-GENERIC
K940725 · HQY
Yon'S Jay Enterprise Co.
Ophthalmic · 424d
Cleared Apr 18, 1995
FRINDLEY ENTERPRISE CO
K942142 · HQY
Frindley Enterprise Co., Ltd.
Ophthalmic · 350d
Cleared Apr 18, 1995
INFINITECH ASPIRATING LASER PROBE
K946135 · HQE
Surgical Technologies, Inc.
Ophthalmic · 123d
Cleared Apr 18, 1995
STAND, INFUSION
K946201 · FOX
Medical Specialties, Inc.
General Hospital · 118d
Cleared Apr 18, 1995
THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)
K950175 · EIA
Aqua-Air Medical Devices, Inc.
Dental · 91d
Cleared Apr 18, 1995
WOUND CLOSURE/LACERATION TRAY
K950295 · LRO
Customed, Inc.
General & Plastic Surgery · 84d
Cleared Apr 18, 1995
ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS
K950301 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 83d
Cleared Apr 18, 1995
TSI WILLEN-REICH NEEDLE
K950726 · GCJ
Tahoe Surgical Instruments P.R., Inc.
General & Plastic Surgery · 61d
Cleared Apr 18, 1995
BIPOLAR SNARE
K950776 · GAE
Cook Urological, Inc.
General & Plastic Surgery · 56d
Cleared Apr 18, 1995
SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER)
K950819 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 54d
Cleared Apr 18, 1995
PROFORM POROUS ACETABULAR ASSEMBLY
K950827 · LPH
Stelkast Company
Orthopedic · 54d
Cleared Apr 18, 1995
LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER
K951215 · GEX
Heraeus Surgical, Inc.
General & Plastic Surgery · 32d
Cleared Apr 18, 1995
PRO-LOCK
K951236 · DYH
Health-Dent Intl., Inc.
Dental · 29d
Cleared Apr 18, 1995
HARMONY LINE KF
K951297 · EJT
Ivoclar North America, Inc.
Dental · 27d
Cleared Apr 18, 1995
MAXIGOLD KF
K951298 · EJT
Ivoclar North America, Inc.
Dental · 27d
Cleared Apr 18, 1995
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K951301 · LPH
Depuy, Inc.
Orthopedic · 27d
Cleared Apr 18, 1995
ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
K951423 · BTA
Impact Instrumentation, Inc.
General & Plastic Surgery · 22d
Cleared Apr 18, 1995
SUNGLASSES
K951439 · HQY
Long Train Enterprise Co., Ltd.
Ophthalmic · 22d
Cleared Apr 18, 1995
DERMAGRAN HYDROPHILIC OINTMENT
K951499 · KMF
Derma Sciences, Inc.
General & Plastic Surgery · 64d
Cleared Apr 17, 1995
AUTOSTAT II ANTI-TPO
K943580 · JNL
Cogent Diagnotics , Ltd.
Immunology · 269d
Cleared Apr 17, 1995
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · LRM
Elias U.S.A., Inc.
Immunology · 223d