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
166177–166200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1980
DISPENSING SEROLOGICAL PIPET
K801437 · JTC
Amt Corp.
Microbiology · 25d
Cleared Jul 14, 1980
P-S SURGICAL DRAIN
K801442 · GCY
Pudenz-Schulte Medical Research Corp.
General & Plastic Surgery · 24d
Cleared Jul 14, 1980
P-S SUCTION RESERVOIR
K801443 · GCY
Pudenz-Schulte Medical Research Corp.
General & Plastic Surgery · 24d
Cleared Jul 14, 1980
SKIN STAPLE REMOVER #523770
K801444 · GDT
Edward Weck, Inc.
General & Plastic Surgery · 24d
Cleared Jul 14, 1980
SKIN STAPLER HANDLE 523700/CARTRIDGES
K801445 · GAG
Edward Weck, Inc.
General & Plastic Surgery · 24d
Cleared Jul 14, 1980
OROTRACHEAL INTUBATION ENDOSCOPE
K801452 · CCW
Olympus Corp.
Anesthesiology · 21d
Cleared Jul 14, 1980
ACCU-CORE DISPOSABLE BIOPSY NEEDLE
K801457 · GAA
Medline Industries, Inc.
General & Plastic Surgery · 20d
Cleared Jul 14, 1980
MICRO CLIP STERILIZING CASE #65199
K801470 · FSM
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Jul 14, 1980
EZ ON SAFETY PONCHO
K801489 · KNO
Skil-Care Corp.
Physical Medicine · 18d
Cleared Jul 14, 1980
DIGOXIN EIA KIT
K801490 · LCS
M.A. Bioproducts
Toxicology · 18d
Cleared Jul 14, 1980
HI-M-TEST FOR METHADONE TEST #2
K801509 · DIW
Technam, Inc.
Toxicology · 14d
Cleared Jul 14, 1980
TIMETER PRODUCED PURRITAN BENNETT O2 ADP
K801514 · BYX
Timeter Instrument Corp.
Anesthesiology · 14d
Cleared Jul 14, 1980
PRE-DENT SYSTEM MODIFIED
K801516 · KSS
Pre-Dent System
Hematology · 13d
Cleared Jul 14, 1980
MODEL 379 WXYGEN CONCENTRATOR
K801523 · CAW
Stanley Aviation Corp.
Anesthesiology · 13d
Cleared Jul 14, 1980
LARES AIR PRESSURE GAUGE
K801534 · EIA
Lares Manufacturing Co., Inc.
Dental · 11d
Cleared Jul 14, 1980
PORTA-FIB LPD
K801544 · LDD
Narco Bio-Systems
Cardiovascular · 7d
Cleared Jul 14, 1980
MODEL R11 SINGLE CHANNEL CHART RECORDER
K801549 · DSF
Medasonics, Inc.
Cardiovascular · 7d
Cleared Jul 08, 1980
VASCULAB BI-DIRECTIONAL DOPPLER, #D10
K800768 · JAF
Medasonics, Inc.
Radiology · 92d
Cleared Jul 08, 1980
NITRATE SWAB-RAPID TEST
K800803 · JXB
Remel Co.
Microbiology · 89d
Cleared Jul 08, 1980
HIPPUR-ASE TUBES
K800816 · JTO
Microchemical Specialities, Co.
Microbiology · 88d
Cleared Jul 08, 1980
AVL #980 ELECTROLYTE ANALYZER
K801011 · JGS
Gauntlet Technology Corp.
Chemistry · 74d
Cleared Jul 08, 1980
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
K801020 · CFT
Travenol Laboratories, S.A.
Chemistry · 69d
Cleared Jul 08, 1980
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
K801038 · DTD
Intermedics, Inc.
Cardiovascular · 67d
Cleared Jul 08, 1980
MULTICOR (GAMMA) MODEL 336 & MODEL 337
K801106 · DXY
Cordis Corp.
Cardiovascular · 60d