FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86689–86712 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1999
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100...
K990210 · LYY
Mexpo Intl., Inc.
General Hospital · 67d
Cleared Mar 29, 1999
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
K990267 · LZA
Shanghai Palomar Mountain Industries,...
General Hospital · 60d
Cleared Mar 29, 1999
POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
K990299 · LZA
Shanghai Palomar Mountain Industries,...
General Hospital · 56d
Cleared Mar 29, 1999
TUTOPLUS IV ADMINISTRATION SET
K990388 · FPA
Myco Medical Supplies, Inc.
General Hospital · 49d
Cleared Mar 29, 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
K990415 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 47d
Cleared Mar 29, 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990420 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 47d
Cleared Mar 26, 1999
MICRINS MICRO ANASTOMOSIS CLAMP
K982278 · DXC
Micrins Surgical, Inc.
Cardiovascular · 270d
Cleared Mar 26, 1999
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
K982414 · KDI
Gambro Healthcare
Gastroenterology & Urology · 256d
Cleared Mar 26, 1999
DORNIER MEDILAS H/2
K984591 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 88d
Cleared Mar 26, 1999
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
K990050 · FGB
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 78d
Cleared Mar 26, 1999
GLIADIN IGG ELISA TEST SYSTEM
K990204 · MST
Zeus Scientific, Inc.
Immunology · 64d
Cleared Mar 26, 1999
DIGISCOPE OPHTHALMIC CAMERA
K990205 · HKI
Eye Tel Imaging, Inc.
Ophthalmic · 64d
Cleared Mar 26, 1999
GLIADIN IGA ELISA TEST SYSTEM
K990207 · MST
Zeus Scientific, Inc.
Immunology · 64d
Cleared Mar 26, 1999
DUODERM HYDROACTIVE GEL WOUND DRESSING
K990368 · MGQ
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 46d
Cleared Mar 26, 1999
ESOPHAGEAL INTUBATION DETECTOR
K990556 · BTR
Wolfe Tory Medical, Inc.
Anesthesiology · 32d
Cleared Mar 26, 1999
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
K990657 · MNH
Corin USA
Orthopedic · 25d
Cleared Mar 26, 1999
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
K990685 · JWY
Ab Biodisk
Microbiology · 23d
Cleared Mar 26, 1999
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
K990687 · PKL
Olympus Optical, Co.
Gastroenterology & Urology · 25d
Cleared Mar 26, 1999
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN...
K990786 · LAG
Princeton BioMeditech Corp.
Toxicology · 16d
Cleared Mar 26, 1999
C1 ULTRASOUND SYSTEM
K990806 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Mar 25, 1999
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798 · KWQ
Osteonics Corp.
Orthopedic · 227d
Cleared Mar 25, 1999
BCI MINI-TORR PLUS, MODEL 6004
K984618 · DXN
Bci Intl., Inc.
Cardiovascular · 86d
Cleared Mar 25, 1999
JELDENT MULTICRYL
K990056 · EBI
J.F. Jelenko & Co., Inc.
Dental · 77d
Cleared Mar 25, 1999
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND...
K990072 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 73d