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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
159217–159240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 24, 1982
TONSIL DISSECTORS
K822187 · KTG
Kelleher Corp.
Ear, Nose, Throat · 32d
Cleared Aug 24, 1982
TONSIL SNARES
K822188 · KBZ
Kelleher Corp.
Ear, Nose, Throat · 32d
Cleared Aug 24, 1982
FORCEPS FOR USE WITH RIGID ENDOSCOPES
K822193 · JEK
Kelleher Corp.
Ear, Nose, Throat · 32d
Cleared Aug 24, 1982
SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES
K822210 · DWF
3M Health Care, Sarns
Cardiovascular · 29d
Cleared Aug 24, 1982
GUIDING CATHETER
K822243 · DQO
Interventional Medical, Inc.
Cardiovascular · 28d
Cleared Aug 24, 1982
CO2/CI STANDARDS
K822289 · JIX
Gilford Diagnostics
Chemistry · 22d