Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
160057–160080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1982
EAR SNARES
K822199 · JZD
Kelleher Corp.
Ear, Nose, Throat · 33d
Cleared Aug 25, 1982
DISPOSABLE TAIYANG SYRINGE
K822238 · FMF
S.D. Sunnyland Enterprises, Inc.
General Hospital · 28d
Cleared Aug 25, 1982
RASPS
K822253 · JYY
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
RIGID SUCTION TIPS
K822255 · KTR
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
ESOPHAGEAL BOUGIES
K822258 · KCD
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
ADENOTOMES
K822262 · KBH
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
ROSEN'S STAPES NEEDLE EXPLORER
K822277 · KAK
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
LANCETS FOR EAR SURGERY
K822279 · KTG
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
DISPOSABLE DISPENSING-SPREAD PIPETS
K822292 · LIB
American Dade
Chemistry · 23d
Cleared Aug 25, 1982
ANTIMICROBIAL REMOVAL DEVICE (ARD)
K822344 · LJF
Marion Laboratories, Inc.
Microbiology · 20d
Cleared Aug 25, 1982
LIDOCAINE FLUORESCENT IMMUNOASSAY
K822347 · KLR
American Diagnostic Corp.
Toxicology · 19d
Cleared Aug 25, 1982
HAEMOPHILUS ID PLATE
K822377 · JSH
Granite Diagnostics, Inc.
Microbiology · 19d
Cleared Aug 25, 1982
U.V.A.C. HANDLER SET
K822382 · HHK
American Hospital Supply Corp.
Obstetrics & Gynecology · 16d
Cleared Aug 25, 1982
MYOCUR BLADE PAC
K822392 · HMN
Myocure, Inc.
General & Plastic Surgery · 16d
Cleared Aug 24, 1982
ANGIOGRAPHIC CATHETER
K821816 · DQO
Medi-Tech, Inc.
Cardiovascular · 64d
Cleared Aug 24, 1982
HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85
K821942 · DRT
Harvey-Bostwick, Inc.
Cardiovascular · 56d
Cleared Aug 24, 1982
BERMAN ANGIOGRAPHIC BALLOON CATHETER
K822033 · DQO
Ziehm International, Inc.
Cardiovascular · 43d
Cleared Aug 24, 1982
BALLOON WEDGE PRESSURE CATHETER
K822034 · DYG
Ziehm International, Inc.
Cardiovascular · 43d
Cleared Aug 24, 1982
GAMBRO PUMP CONSOLE CSL
K822068 · DTQ
Gambro, Inc.
Cardiovascular · 41d
Cleared Aug 24, 1982
PUMP MODULES PMO LO-110-PMD 10-210
K822071 · DWB
Gambro, Inc.
Cardiovascular · 41d
Cleared Aug 24, 1982
HIGH PRESSURE CONTRAST INJECTION LINE
K822100 · DQO
Namic
Cardiovascular · 39d
Cleared Aug 24, 1982
IDS STAPHYLOCHROME TEST
K822144 · JWX
Innovative Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Aug 24, 1982
ETHICON TEMPORARY CARDIAC PACING WIRE
K822155 · LOF
Ethicon, Inc.
Orthopedic · 32d
Cleared Aug 24, 1982
INCUS NIPPERS
K822170 · JYR
Kelleher Corp.
Ear, Nose, Throat · 32d