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
160969–160992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1982
ACCU-STAPH
K820347 · LHT
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 24d
Cleared Mar 04, 1982
ANALGESIA BREATHING CIRCUIT
K820352 · CAI
Cryogentics Northwest, Inc.
Anesthesiology · 24d
Cleared Mar 04, 1982
DISPOSABLE DIAPHRAGM DOMES
K820355 · DRS
Medex, Inc.
Cardiovascular · 24d
Cleared Mar 04, 1982
AALTO LDH ISOENZYME CONTROL SERUM
K820360 · JJT
Aalto Scientific, Ltd.
Chemistry · 23d
Cleared Mar 04, 1982
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
K820392 · LAS
Ortho Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Mar 04, 1982
UNIVERSAL TESTING & ANALYSIS SYSTEMS
K820414 · GWF
Lkc Technologies, Inc.
Neurology · 20d
Cleared Mar 04, 1982
#505 PORT. VITAL FUNCTIONS NEONATAL MON
K820416 · DRT
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Mar 04, 1982
#506 PORT. VITAL FUNCTIONS NEONATAL MON
K820417 · DRT
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Mar 04, 1982
P1808 MOBILE C-ARM IMAGE INTENSIFIER
K827087
Precise Optics
Radiology · 41d
Cleared Mar 04, 1982
RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC
K827125
Tecnomed, Inc.
Radiology · 28d
Cleared Mar 02, 1982
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
K812802 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 147d
Cleared Mar 02, 1982
SSD-240 ULTRASONIC SCANNER
K813397 · IYO
U. S. A. Imaging Corp.
Radiology · 88d
Cleared Mar 02, 1982
CUTTERBOND ZINC PHOSPHATE CEMENT
K813532 · EMA
Cutter Laboratories, Inc.
Dental · 75d
Cleared Mar 02, 1982
UVEX MINI-SPECS
K813548 · HOI
Bacou USA, Inc. and Uvex Safety, Inc.
Ophthalmic · 71d
Cleared Mar 02, 1982
LUXOR PORCELAIN
K820057 · EIH
Jeneric Ind.
Dental · 50d
Cleared Mar 02, 1982
XENON DELIVERY SYSTEM
K820143 · IYT
Vital Signs, Inc.
Radiology · 42d
Cleared Mar 02, 1982
ALLTEK BROMPTON ENCODER
K820145 · DXK
Alltek Hospital Supplies , Ltd.
Cardiovascular · 42d
Cleared Mar 02, 1982
XOMED THERMAL MYRINGOTOMY SYSTEM
K820157 · HQP
Xomed, Inc.
Ophthalmic · 42d
Cleared Mar 02, 1982
SUBCLAVIAN INSERTION KIT
K820171 · FRG
Clinipad Corp.
General Hospital · 40d
Cleared Mar 02, 1982
SYBRON/KERR COMMAND
K820182 · EBF
Sybron Corp.
Dental · 39d
Cleared Mar 02, 1982
ADD'L TERMINAL SUPPORT FOR STAR BASIC
K820244 · IYX
General Electric Co.
Radiology · 32d
Cleared Mar 02, 1982
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · DWS
Howmedica Corp.
Cardiovascular · 29d
Cleared Mar 02, 1982
EXTRACTOR III
K820292
The Anspach Effort, Inc.
General & Plastic Surgery · 27d
Cleared Mar 02, 1982
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
K820304 · FJI
Gambro, Inc.
Gastroenterology & Urology · 26d