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
103225–103248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1995
POWDER FREE PATIENT EXAMINATION GLOVES
K950467 · LYY
Intl. Trade Management Co.
General Hospital · 81d
Cleared Apr 25, 1995
POWDER FREE STERILE LATEX SURGEONS GLOVES
K950468 · KGO
Intl. Trade Management Co.
General Hospital · 81d
Cleared Apr 25, 1995
PERVAL SURGICAL GOWN (MARKETING NAME)
K950504 · FYA
Standard Textile Co., Inc.
General Hospital · 78d
Cleared Apr 25, 1995
FIKO FO
K950610 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 74d
Cleared Apr 25, 1995
ENDOSCOPES AND ACCESSORIES
K950612 · GCJ
Storz Instrument Co.
General & Plastic Surgery · 74d
Cleared Apr 25, 1995
BIODERM MEDICAL FOAM WOUND DRESSING
K950619 · KMF
Bioderm, Inc.
General & Plastic Surgery · 74d
Cleared Apr 25, 1995
MACRO SUCTION TUBE MODEL NO 10061
K950754 · GCY
Dlp, Inc.
General & Plastic Surgery · 67d
Cleared Apr 25, 1995
HEART RATE VARIABILITY SOFTWARE OPTION
K950779 · DPS
Spacelabs, Inc.
Cardiovascular · 63d
Cleared Apr 25, 1995
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · JWY
Baxter Diagnostics, Inc.
Microbiology · 62d
Cleared Apr 25, 1995
CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER
K951123 · LRJ
Micro-Aseptic Products, Inc.
General Hospital · 60d
Cleared Apr 25, 1995
KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME
K951252 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 36d
Cleared Apr 25, 1995
PHENO-CEN SPRAY DISINFECTANT DEODORANT
K951317 · LRJ
Central Solutions, Inc.
General Hospital · 33d
Cleared Apr 25, 1995
LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH...
K951328 · GEI
Labeltape Meditect, Inc.
General & Plastic Surgery · 33d
Cleared Apr 25, 1995
Q4.5-5.0PB-4.5
K951342 · LRJ
Central Solutions, Inc.
General Hospital · 33d
Cleared Apr 25, 1995
ENDOPATH OPTICAL ACCESS NEEDKLE
K951444 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 27d
Cleared Apr 25, 1995
KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
K951488 · KNY
The Kendal Co.
Gastroenterology & Urology · 25d
Cleared Apr 25, 1995
BUTTON LUBRICATOR
K951713 · FHX
Fibertech Instruments, Inc.
Gastroenterology & Urology · 11d
Cleared Apr 24, 1995
URINE REAGENT STRIPS-8 PARAMETERS
K943436 · JJB
Teco Diagnostics
Chemistry · 280d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-SPS
K945880 · JTO
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
K945881 · JTO
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-BILE
K945882 · JTO
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
K945883 · JTO
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
GORE-TEX DUALMESH PLUS BIOMATERIAL
K946106 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 131d
Cleared Apr 24, 1995
GORE-TEX MYCROMESH PLUS BIOMATERIAL
K946107 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 131d