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
81601–81624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
K001670 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
K001671 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K001674 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 29d
Cleared Jun 30, 2000
VSCORE WITH EKG SIGNAL GATING
K001682 · JAK
Vital Images, Inc.
Radiology · 29d
Cleared Jun 30, 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 28d
Cleared Jun 30, 2000
AGILENT COMPONENT MONITORING SYSTEM
K001722 · MHX
Agilent Technologies Deutschland GmbH
Cardiovascular · 24d
Cleared Jun 30, 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K001776 · MWI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 30, 2000
QUART ARTERIAL FILTER, MODEL HBF 140
K001787 · DTM
Jostra Medizintechnik AG
Cardiovascular · 17d
Cleared Jun 30, 2000
STEATHSTATION TREATMENT GUIDANCE PLATFORM
K001801 · HAW
Medtronic Surgical Navigation
Neurology · 16d
Cleared Jun 30, 2000
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K001834 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 14d
Cleared Jun 30, 2000
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K001862 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 11d
Cleared Jun 30, 2000
UNICORN MODEL SYS0630
K001888 · KPS
Danish Diagnostic Development A/S
Radiology · 15d
Cleared Jun 30, 2000
RECTOSIGHT RS 300-04
K994130 · FER
Sightline Technologies , Ltd.
Gastroenterology & Urology · 206d
Cleared Jun 29, 2000
URANUS, COMFORTOUCH LASER SYSTEM
K001031 · GEX
Laser Max Medical Technologies Corp.
General & Plastic Surgery · 91d
Cleared Jun 29, 2000
SPINE SYSTEM EVOLUTION
K001080 · KWP
Aesculap, Inc.
Orthopedic · 86d
Cleared Jun 29, 2000
ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL...
K001150 · GEI
Novasys Medical, Inc.
General & Plastic Surgery · 80d
Cleared Jun 29, 2000
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC)...
K001227 · LPL
Opti-Centre Laboratories
Ophthalmic · 73d
Cleared Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417 · DKZ
Roche Diagnostics Corp.
Toxicology · 55d
Cleared Jun 29, 2000
SUGAR CHEX ONE
K001443 · JJX
Streck Laboratories, Inc.
Chemistry · 52d
Cleared Jun 29, 2000
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL,...
K001705 · GYB
Chester Labs, Inc.
Neurology · 24d
Cleared Jun 29, 2000
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
K992757 · GEX
Cynosure, Inc.
General & Plastic Surgery · 318d
Cleared Jun 29, 2000
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
K993154 · GEX
A.R.C. Laser Corp.
General & Plastic Surgery · 282d
Cleared Jun 29, 2000
NICOLET EME LEGEND TC22
K993939 · IYN
Nicolet Biomedical
Radiology · 223d
Cleared Jun 28, 2000
BD DIRECTIGEN FLU A+B
K001364 · PSZ
Bd Becton Dickinson Vacutainer...
Microbiology · 58d