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
135169–135192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1988
VITALOGRAPH-EC60 HYDROGEN MONITOR
K874892 · NRH
Vitalograph , Ltd.
Chemistry · 184d
Cleared Jun 02, 1988
INTRO-REDUCER (NASOGASTRIC TUBE)
K875232 · KNT
Health Improvement Assoc.
Gastroenterology & Urology · 163d
Cleared Jun 02, 1988
WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION
K880879 · DQK
Ppg Industries, Inc.
Cardiovascular · 93d
Cleared Jun 02, 1988
HYGEIA GC TEST
K881064 · LIR
Hygeia Sciences
Microbiology · 80d
Cleared Jun 02, 1988
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
K881436 · JJY
Hichem Diagnostics
Chemistry · 58d
Cleared Jun 02, 1988
DIAMOND'S MEDIUM MODIFIED
K881995 · KZI
Remel Co.
Microbiology · 21d
Cleared Jun 02, 1988
MODIFIED SHARPLAN MODEL 1020 CO2 LASER
K882180 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 30d
Cleared Jun 01, 1988
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · DPT
General Electric Co.
Cardiovascular · 292d
Cleared Jun 01, 1988
NEUROPROBE
K874018 · ETN
Inovx, Inc.
Ear, Nose, Throat · 243d
Cleared Jun 01, 1988
ACCUCOM 2
K874138 · DPT
Datascope Corp.
Cardiovascular · 232d
Cleared Jun 01, 1988
KERR XR BOND
K880250 · EMA
Kerr Corporation (Danbury)
Dental · 133d
Cleared Jun 01, 1988
KERR XR IONOMER
K880251 · EMA
Kerr Corporation (Danbury)
Dental · 133d
Cleared Jun 01, 1988
FACTOR II PROSTHETIC SILICONE ELASTOMER
K880329 · GBI
Factor, Ii, Inc.
General & Plastic Surgery · 127d
Cleared Jun 01, 1988
SAFESKIN STERILE SURGEONS GLOVES
K880446 · KGO
Safeskin Corp.
General Hospital · 120d
Cleared Jun 01, 1988
LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
K880591 · HHR
Laser Peripherals, LLC
Obstetrics & Gynecology · 111d
Cleared Jun 01, 1988
SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER
K880900 · HEM
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 91d
Cleared Jun 01, 1988
PUDENDAL/LOCAL ANESTESIA BLOCK TRAY
K880988 · KNE
Bd Becton Dickinson Vacutainer...
Obstetrics & Gynecology · 85d
Cleared Jun 01, 1988
CONTAC, A DENTIN SEALANT
K881026 · LBH
Harry J. Bosworth Co.
Dental · 83d
Cleared Jun 01, 1988
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
K881185 · HEM
Philips Medical Systems (Cleveland),...
Obstetrics & Gynecology · 72d
Cleared Jun 01, 1988
RIA-QUICK
K881194 · JQP
Quantitative Technologies, Inc.
Chemistry · 72d
Cleared Jun 01, 1988
ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE
K881224 · GAE
Acufex Microsurgical, Inc.
General & Plastic Surgery · 71d
Cleared Jun 01, 1988
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
K881351 · JHY
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
Cleared Jun 01, 1988
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · CFJ
Abbott Laboratories
Chemistry · 55d
Cleared Jun 01, 1988
SYNCHRON CX(TM)5 CLINICAL ANALYZER
K881495 · JJE
Beckman Instruments, Inc.
Chemistry · 54d