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
126265–126288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1990
POLAMEDCO NASOPAHARYNGEAL AIRWAY
K900456 · BTQ
Polamedco, Inc.
Anesthesiology · 79d
Cleared Apr 19, 1990
AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791
K900666 · CGX
American Research Products Co.
Chemistry · 65d
Cleared Apr 19, 1990
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
K900667 · CFJ
American Research Products Co.
Chemistry · 65d
Cleared Apr 19, 1990
MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA
K900689 · IYX
Adac Laboratories
Radiology · 65d
Cleared Apr 19, 1990
MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
K900708 · LEH
Innotron of Oregon, Inc.
Toxicology · 66d
Cleared Apr 19, 1990
PISTON IRRIGATION TRAY
K900737 · EYN
Orion Life Systems, Inc.
General & Plastic Surgery · 62d
Cleared Apr 19, 1990
CARDIOVUE CFS-100
K900893 · JAA
Bv Medical Equipment Co.
Radiology · 51d
Cleared Apr 19, 1990
5000/5000C MULTI-FORMAT CAMERAS FOR NUCLEAR MEDI.
K900897 · LMC
International Imaging Electronics
Radiology · 51d
Cleared Apr 19, 1990
9000 ECONOMICAL 14 X 17 VIDEO IMAGER
K900898 · LMC
International Imaging Electronics
Radiology · 51d
Cleared Apr 19, 1990
MANUAL WHEELCHAIR
K900938 · IOR
Advanced Mobility Systems Corp.
Physical Medicine · 50d
Cleared Apr 19, 1990
E-CLIP
K900982 · LDF
Joel Cohen & Esther R. Cohen
Cardiovascular · 48d
Cleared Apr 19, 1990
FILT-R-ALL BACTERIAL/VIRAL FILTER
K900990 · CAH
Inhalation Plastics
General Hospital · 48d
Cleared Apr 19, 1990
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 44d
Cleared Apr 19, 1990
SPS 550-IPS (INTEGRATED PATIENT STATION)
K901038 · FIL
Baxter Healthcare Corp
Gastroenterology & Urology · 44d
Cleared Apr 19, 1990
NO-STICK COMPOSITE INSTRUMENT DIP
K901050 · EBD
Pulpdent Corp.
Dental · 45d
Cleared Apr 19, 1990
MULTICONSTITUENT SERUM RANGE LINEARITY #88234
K901115 · JJY
Hichem Diagnostics
Chemistry · 41d
Cleared Apr 19, 1990
SONY VO-5800H VIDEOCASSETTE RECORDER
K901153 · JAA
Sony Medical Electronics Co.
Radiology · 37d
Cleared Apr 19, 1990
LITEBOX DIAGNOSTIC REVIEW WORKSTATION
K901158 · LLZ
Siemens Gammasonics, Inc.
Radiology · 37d
Cleared Apr 19, 1990
CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
K901226 · CIC
Technicon Instruments Corp.
Chemistry · 36d
Cleared Apr 19, 1990
GRASP (GRIGG-RUSSEL AIR SUPPORT PILLOW)
K901375 · INW
Medical Plastics Laboratory, Inc.
Physical Medicine · 28d
Cleared Apr 19, 1990
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
K901578 · CFT
Diagnostic Products Corp.
Chemistry · 15d
Cleared Apr 18, 1990
EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.
K891556 · ESD
Green Light Import Export Co., Inc.
Ear, Nose, Throat · 397d
Cleared Apr 18, 1990
MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
K896862 · DSI
Del Mar Avionics
Cardiovascular · 133d
Cleared Apr 18, 1990
MODEL AUDINA ITE HEATING AID
K897024 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 120d