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
110593–110616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1994
COMPACT MASK
K932347 · KGB
Vital Signs, Inc.
Anesthesiology · 241d
Cleared Jan 10, 1994
IMMULITE ESTRADIOL
K932926 · CHP
Diagnostic Products Corp.
Chemistry · 209d
Cleared Jan 10, 1994
ROYL-DERM WOUND HYDROGEL DRESSING
K932973 · MGQ
Renaissance Medical, Inc.
General & Plastic Surgery · 210d
Cleared Jan 10, 1994
SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS
K933007 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 203d
Cleared Jan 10, 1994
I.V. LINK
K933366 · FPO
Deville Laboratories, Inc.
General Hospital · 185d
Cleared Jan 10, 1994
R & D BATTERIES, INC. PART # 5003, 5198, 5253
K933642 · FLL
R & D Batteries, Inc.
General Hospital · 167d
Cleared Jan 10, 1994
ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE
K933817 · MGQ
Renaissance Medical, Inc.
General & Plastic Surgery · 159d
Cleared Jan 10, 1994
PILLING LAPAROSCOPIC INSTRUMENTATION
K934427 · GEI
Pilling Co.
General & Plastic Surgery · 122d
Cleared Jan 10, 1994
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
K934727 · DWS
Cardiac Pacemakers, Inc.
Cardiovascular · 101d
Cleared Jan 10, 1994
ACTIVE ANDROSTANEDIOL GLUCURONIDE
K934751 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 98d
Cleared Jan 10, 1994
BRENNEN MEDICAL STERILE SALINE SOLUTION
K935060 · KMF
Brennen Medical, Inc.
General & Plastic Surgery · 82d
Cleared Jan 07, 1994
ARGENCO Y +
K915612 · EJT
Argen Precious Metals, Inc.
Dental · 753d
Cleared Jan 07, 1994
EXACT-TOUCH
K915844 · HHT
Baal Assoc., Inc.
Obstetrics & Gynecology · 743d
Cleared Jan 07, 1994
FUTURA TEXTURE-TRAKKED TOTAL HIP STEM
K921382 · LWJ
Arthronics, Inc.
Orthopedic · 655d
Cleared Jan 07, 1994
PSL TOTAL HIP REPLACEMENT SYSTEM
K922500 · LPH
Biopro, Inc.
Orthopedic · 590d
Cleared Jan 07, 1994
PERFECTA TOTAL HIP SYSTEM
K923243 · JDI
Orthomet, Inc.
Orthopedic · 554d
Cleared Jan 07, 1994
CLARUS SERIES 2100 ENDOSCOPE
K923514 · HRX
Clarus Medical Systems, Inc.
Orthopedic · 540d
Cleared Jan 07, 1994
HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
K925536 · KWY
Orthomet, Inc.
Orthopedic · 431d
Cleared Jan 07, 1994
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED
K925682 · LZO
Biopro, Inc.
Orthopedic · 427d
Cleared Jan 07, 1994
AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY
K925837 · JWH
Depuy, Inc.
Orthopedic · 415d
Cleared Jan 07, 1994
VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM
K930248 · ELW
Crown Delta Corp.
Dental · 353d
Cleared Jan 07, 1994
OSTEON ADAPTOR/CRADLE
K930319 · HWE
United American Medical Co., Inc.
Orthopedic · 350d
Cleared Jan 07, 1994
POWERED SURGICAL INSTRUMENT ACCESSORY
K930363 · HWE
Intenn Engineering, Inc.
Orthopedic · 346d
Cleared Jan 07, 1994
DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID
K930588 · GAM
Davis & Geck, Inc.
General & Plastic Surgery · 337d