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
85945–85968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1999
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM
K983588 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 195d
Cleared Apr 26, 1999
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
K983776 · HGX
Evenflo Co., Inc.
Obstetrics & Gynecology · 182d
Cleared Apr 26, 1999
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
K990327 · GKZ
Coulter Corp.
Hematology · 83d
Cleared Apr 26, 1999
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
K990384 · CAF
Piper Medical Products
Anesthesiology · 77d
Cleared Apr 26, 1999
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED...
K991151 · HWC
Vilex, Inc.
Orthopedic · 20d
Cleared Apr 26, 1999
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX,...
K991197 · HWC
Vilex, Inc.
Orthopedic · 19d
Cleared Apr 23, 1999
COWBOY XV
K981311 · JOW
Kci New Technologies, Inc.
Cardiovascular · 378d
Cleared Apr 23, 1999
CHALLENGE TEST PACK
K983451 · JOJ
North American Science Assoc., Inc.
General Hospital · 205d
Cleared Apr 23, 1999
SYNTHETIC SERUM SUBSTITUTE (SSS)
K983579 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 192d
Cleared Apr 23, 1999
SIDEKICK INFUSION KIT
K990425 · FRN
I-Flow Corp.
General Hospital · 71d
Cleared Apr 23, 1999
ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
K990427 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 71d
Cleared Apr 23, 1999
EBI VUECATH ENDOSCOPIC SYSTEN
K990459 · HRX
Electro-Biology, Inc.
Orthopedic · 70d
Cleared Apr 23, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
K990485 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Apr 23, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.
K990486 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Apr 23, 1999
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K990526 · LYY
Ssn Gloves (M) Sdn Bhd
General Hospital · 63d
Cleared Apr 23, 1999
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES
K990527 · LYY
Ssn Gloves (M) Sdn Bhd
General Hospital · 63d
Cleared Apr 23, 1999
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
K990584 · EFQ
Broadline Medical Industries
General & Plastic Surgery · 59d
Cleared Apr 23, 1999
CAVIT LC
K990982 · EBF
Espe Dental AG
Dental · 30d
Cleared Apr 23, 1999
RAPIDFLAP CRANIAL CLAMP
K991029 · GXN
Walter Lorenz Surgical, Inc.
Neurology · 25d
Cleared Apr 23, 1999
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT...
K991044 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 24d
Cleared Apr 23, 1999
PBN DRAINAGE CATHETER GUIDEWIRES
K991097 · KNY
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Apr 23, 1999
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
K991138 · EBZ
Lysta A/S
Dental · 18d
Cleared Apr 23, 1999
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN...
K991294 · KZE
Medi-Ject Corp.
General Hospital · 8d
Cleared Apr 22, 1999
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
K990214 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 90d